Visual Abstract
Keywords: acute kidney injury, chronic kidney disease, randomized controlled trials, angiography, fluid administration
Abstract
Background and objectives
Contrast-associated AKI may result in higher morbidity and mortality. Intravenous fluid administration remains the mainstay for prevention. There is a lack of consensus on the optimal administration strategy. We studied the association of periprocedure fluid administration with contrast-associated AKI, defined as an increase in serum creatinine of at least 25% or 0.5 mg/dl from baseline at 3–5 days after angiography, and 90-day need for dialysis, death, or a 50% increase in serum creatinine.
Design, setting, participants, & measurements
We conducted a secondary analysis of 4671 PRESERVE participants who underwent angiographic procedures. Although fluid type was randomized, strategy of administration was at the discretion of the clinician. We divided the study cohort into quartiles by total fluid volume. We performed multivariable logistic regression, adjusting for clinically important covariates. We tested for the interaction between fluid volume and duration of fluid administration, categorized as <6 or ≥6 hours.
Results
The mean (SD) age was 70 (8) years, 94% of participants were male, and median (interquartile range) eGFR was 60 (41–60) ml/min per 1.73 m2. The range of fluid administered was 89–882 ml in quartile 1 and 1258–2790 ml in quartile 4. Compared with the highest quartile (quartile 4) of fluid volume, we found a significantly higher risk of the primary outcome in quartile 1 (adjusted odds ratio, 1.58; 95% confidence interval, 1.06 to 2.38) but not in quartiles 2 and 3 compared with quartile 4. There was no difference in the incidence of contrast-associated AKI across the quartiles. The interaction between volume and duration was not significant for any of the outcomes.
Conclusions
We found that administration of a total volume of 1000 ml, starting at least 1 hour before contrast injection and continuing postcontrast for a total of 6 hours, is associated with a similar risk of adverse outcomes as larger volumes of intravenous fluids administered for periods >6 hours. Mean fluid volumes <964 ml may be associated with a higher risk for the primary outcome, although residual confounding cannot be excluded.
Introduction
Contrast-associated AKI is associated with serious adverse outcomes (1,2). There have been significant advancements in the understanding of the pathophysiology of contrast-associated AKI and approaches to the prevention of this iatrogenic condition (2). Intravenous fluid administration remains the mainstay of therapy for prevention (3). Intravenous fluids are believed to decrease the risk of contrast-associated AKI by attenuating the kidney vasoconstriction resulting from contrast administration and by increasing flow through the tubular lumen, which reduces the time that cytotoxic contrast is in contact with tubular epithelial cells (4,5). Several strategies for the administration of intravenous fluids have been used in clinical trials, however, the optimal fluid rate and volume remain unknown.
The Prevention of Serious Adverse Events Following Angiography (PRESERVE) trial, sponsored by the Department of Veterans Affairs (VA) and the National Health and Medical Research Council of Australia, addressed the critical question of which intravenous fluid was the most effective for the prevention of contrast-associated AKI and serious, adverse 90-day outcomes. In patients undergoing angiography at high risk for contrast-associated AKI, there was no benefit of intravenous sodium bicarbonate over sodium chloride for the prevention of death, need for dialysis, persistent decline in kidney function at 90 days, or contrast-associated AKI (6,7), and these results were confirmed in the subgroup of participants who underwent percutaneous coronary intervention (PCI) (8). Nevertheless, there remain several unanswered questions regarding the optimal periprocedural timing of fluid administration, total fluid volume, rate, and duration when considering the individual's risk factors for contrast-associated AKI. Prior studies used wide ranges in the timing of fluid administration, from 4 to 24 hours given before, throughout, and after the procedure (9–12). Reflecting the lack of consensus regarding a fluid administration protocol, the most recent American College of Cardiology (ACC)/American Heart Association/Society of Cardiovascular Angiography and Interventions guideline recommends adequate preprocedural hydration but provides no specific guidance on the amount or duration of fluid administration (13). Other strategies include hemodynamic/left ventricular end-diastolic pressure–guided (14) and device-guided fluid administration (15). However, some of these strategies are not feasible given the requirement for long durations of fluid administration in patients undergoing angiographic procedures in the outpatient setting with same-day discharge (16). Given this issue, the European Society of Urogenital Radiology recommends using intravenous fluid protocols of 3 ml/kg per hour for 1 hour before contrast, followed by infusion of 1 ml/kg per hour for 4–6 hours after the procedure (17). In regard to the optimal total volume of fluid to administer, the evidence is conflicting with concerns raised with both high and low volumes and their possible association with poor outcomes and risk of contrast-associated AKI (18–21). Due to the wide variation in the duration and volumes and the variability in recommendations across professional societies, none of these strategies have been universally adapted and no clear consensus exists on the optimal approach to reduce the risk for contrast-associated AKI and associated adverse outcomes.
In the PRESERVE trial, the type of fluid administered was determined by random assignment, but the volume, rate, and duration of fluid administration were decided by the individual prescribers within specified ranges, which led to a variety of administration patterns. This provided the opportunity to examine the association of these parameters with primary and secondary outcomes. Given the interest in identifying a volume expansion strategy that can be easily implemented in an outpatient setting, in this post hoc analysis of the PRESERVE trial, we sought to determine if the volume of fluid administration was associated with the risk of contrast-associated AKI and 90-day adverse outcomes in high-risk patients undergoing angiography, and whether the association was modified by the duration of fluid administration.
Materials and Methods
Study Population
We conducted a secondary analysis of data from the PRESERVE trial in which patients at high risk for kidney complications undergoing angiographic procedures were randomized using a 2×2 factorial design to receive intravenous 1.26% sodium bicarbonate or intravenous 0.9% sodium chloride in the periprocedure period and 5 days of oral acetylcysteine or oral placebo (NCT01467466). The trial enrolled participants from 53 medical centers across the United States, Australia, New Zealand, and Malaysia (6,7). Overall, 4993 participants were included in the modified intention-to-treat analysis (Figure 1). Participants were excluded from this secondary analysis if they did not undergo the scheduled procedure or had missing information regarding intravenous fluid administration. Participants (n=104) who received fluids beyond 24 hours were not included in this analysis because this duration was unlikely to be used for the prevention of contrast-associated AKI and is not part of any of the guidelines.
Figure 1.
Construction of study cohort. ITT, intention to treat; IV, intravenous.
The inclusion and exclusion criteria for eligibility in the parent protocol (6,7) was previously detailed. Briefly, patients ≥18 years of age with an eGFR of 15–44.9 ml/min per 1.73 m2, or 45–59.9 ml/min per 1.73 m2 among those with diabetes mellitus, who were undergoing coronary or noncoronary angiographic procedures were included. Patients with CKD stage 5, those receiving dialysis, or those who had unstable baseline serum creatinine, decompensated heart failure, emergent angiogram, or receipt of iodinated contrast within the past 7 days were excluded.
Study Design and Variables
The primary outcome was the composite of death, need for dialysis, or a 50% increase in serum creatinine at 90 days after angiography. The secondary outcomes were contrast-associated AKI (defined as an increase in serum creatinine of at least 25% or at least 0.5 mg/dl [44 µmol/L] from baseline at 3–5 days after angiography), the individual components of the primary composite outcome, and hospitalization with acute coronary syndrome, heart failure, or stroke by 90 days. There are several parameters of fluid administration that may affect these outcomes, including total volume (with adverse consequences for both high and low volumes), timing of administration (pre- and/or postangiography), and duration and rate of administration. We focused on two specific analyses: (1) the effect of total volume of fluid administered and (2) the interaction between fluid volume and duration of administration. In the first analysis, we divided the study group into quartiles of total fluid volume administered and determined the association with study outcomes. The quartiles were on the basis of all fluid received before angiography, fluids received during the procedure, and fluids received postprocedure. We chose to divide the cohort into quartiles because it enabled us to detect any differences in the outcomes across a range of fluid volumes that appear to be clinically relevant and reflects the choice of volume of fluid administration prescribed by the clinicians caring for the patient. For the analysis of duration of fluid administration, we dichotomized duration as <6 or ≥6 hours on the basis of considerations for convenience of implementing intravenous fluid protocols in the outpatient setting.
Statistical Analyses
Descriptive statistics were used to summarize baseline characteristics. For comparing baseline descriptive characteristics and primary and secondary outcomes by fluid quartiles, we used chi-squared tests for categoric variables and ANOVA for continuous variables, which were expressed as means and SD, and the Kruskal–Wallis test for continuous variables, which were expressed as medians and interquartile ranges. We used multivariable logistic regression models to assess the relationship between fluid volume in quartiles with the primary and secondary outcomes. Because both the severity of CKD and a history of heart failure may affect the fluid administration strategy, baseline eGFR and history of heart failure were included as covariates in the models. Additionally, we also adjusted for age, the presence of diabetes mellitus, procedure type, inpatient versus outpatient status, and fluid duration. No more than 1.4% of the main covariates were missing, and complete case analysis was used for outcome analysis when values were missing. We also performed a similar analysis with fluid volume as a continuous variable and a cubic spline analysis to determine if an inflection point could be determined for the association of volume with the outcomes.
Because angiographic procedures are being performed increasingly in the outpatient setting, there is a desire to expedite prophylactic fluid administration. Thus, in the multivariable logistic regression models, we also tested for the interaction between fluid volume and duration of fluid administration, dichotomized as <6 or ≥6 hours, by including an interaction term for quartile of fluid volume×duration of fluid administration. Similarly, because patients with more severe reductions in baseline eGFR and those who undergo PCI are thought to be at higher risk for adverse kidney events, we also tested for the interaction of the quartile of fluid administration with these covariates. eGFR was dichotomized at an eGFR <45 versus ≥45 ml/min per 1.73 m2. All analyses were conducted using SAS version 9.4 (SAS Institute, Cary, NC). A P value <0.05 was considered statistically significant. Support for VA/Centers for Medicare and Medicaid Services data was provided by the Department of VA, Office of Research and Development, Cooperative Studies Program (project number CSP 578).
Results
Baseline Characteristics
The final analytic cohort included 4671 patients who underwent coronary or noncoronary angiographic procedures and received intravenous fluids periprocedurally (Figure 1). The mean (SD) total fluid volume administered to the study cohort was 1071 (315) ml (Figure 2). The mean (SD) volume of fluid administered by quartiles was 701 (157) ml for quartile 1 (Q1), 964 (42) ml for Q2, 1140 (65) ml for Q3, and 1478 (217) ml for Q4 (Table 1). The range of fluid administered in each quartile was 89–882 ml for Q1, 883–1034 ml for Q2, 1035–1257 ml for Q3, and 1258–2790 ml for Q4. The mean duration of fluid administration within the quartiles ranged between 6.9 and 9.6 hours, with longer durations associated with higher fluid volumes. Among the quartiles, patients had a mean age of 68–71 years, with the younger patients in Q3 and Q4 receiving more fluid (Table 1). Lower baseline eGFR was associated with less fluid administration (Q1). Patients in Q4 had the highest percentage of diabetes and most PCIs performed, whereas Q1 had the highest percentage of patients with a history of heart failure and inpatient procedures. The urine albumin-creatinine ratio was similar across quartiles.
Figure 2.
Fluid volume administered. (A) Total fluid volume administered, (B) fluid volume administered preprocedure, (C) fluid volume administered during the procedure, and (D) fluid volume administered postprocedure.
Table 1.
Baseline characteristics of study population by quartiles of total fluid volume administered
| Characteristic | Quartiles of Total Fluid Volume | Total (n=4671) | |||
|---|---|---|---|---|---|
| Quartile 1 (n=1169) | Quartile 2 (n=1165) | Quartile 3 (n=1171) | Quartile 4 (n=1166) | ||
| Total volume (ml) | |||||
| Mean (SD) | 701 (157) | 964 (42) | 1140 (65) | 1478 (217) | 1071 (315) |
| Median (IQR) | 744 (625–819) | 970 (929–1000) | 1135 (1086–1195) | 1414 (1325–1556) | 1035 (882–1258) |
| Age (yr), mean (SD) | 71 (9) | 70 (89) | 69 (8) | 68 (85) | 70 (8) |
| Sex, n (%) | |||||
| Female | 131 (11) | 77 (7) | 41 (3) | 48 (4) | 297 (6) |
| Male | 1038 (89) | 1088 (93) | 1130 (96) | 1118 (96) | 4374 (94) |
| eGFR (ml/min per 1.73 m2), median (IQR) | 48 (39–57) | 50 (42–59) | 51 (42–61) | 51 (42–60) | 50 (41–60) |
| eGFR category (ml/min per 1.73 m2), n (%) | |||||
| <30 | 79 (7) | 69 (6) | 70 (6) | 54 (5) | 272 (6) |
| 30–44.9 | 394 (34) | 325 (28) | 305 (26) | 312 (27) | 1336 (29) |
| ≥45 | 675 (59) | 759 (66) | 778 (67) | 787 (68) | 2999 (65) |
| Serum creatinine (mg/dl), median (IQR) | |||||
| At baseline | 1.5 (1.3–1.8) | 1.5 (1.3–1.7) | 1.5 (1.3–1.7) | 1.5 (1.3–1.7) | 1.5 (1.3–1.8) |
| At 4 days | 1.6 (1.3–1.9) | 1.5 (1.3–1.8) | 1.5 (1.3–1.8) | 1.5 (1.3–1.8) | 1.5 (1.3–1.8) |
| At 90 days | 1.5 (1.3–1.9) | 1.5 (1.3–1.8) | 1.5 (1.3–1.8) | 1.5 (1.3–1.7) | 1.5 (1.3–1.8) |
| Contrast, n (%) | |||||
| Iodixanol | 592 (51) | 646 (55) | 691 (59) | 698 (60) | 2627 (56) |
| Low osmolar agent | 577 (49) | 519 (45) | 480 (41) | 468 (40) | 2044 (44) |
| Contrast volume (ml), median (IQR) | 75 (50–112) | 80 (54–125) | 90 (60–135) | 100 (65–163) | 85 (55–135) |
| Urinary albumin-creatine ratio (mg/g), median (IQR) | 61 (15–274) | 50 (11–286) | 53 (12–268) | 52 (11–258) | 55 (12–272) |
| Diabetes mellitus, n (%) | 854 (73) | 911 (78) | 982 (84) | 1035 (89) | 3782 (81) |
| Left ventricular end-diastolic pressure (mm Hg), mean (SD)a | 19 (8.5) | 17 (7.6) | 18 (7.9) | 18 (8.1) | 18 (8.1) |
| History of myocardial infarction, n (%) | 435 (37) | 431 (37) | 389 (33) | 429 (37) | 1684 (36) |
| History of cerebrovascular disease, n (%) | 193 (16) | 182 (16) | 204 (17) | 185 (16) | 764 (16) |
| History of peripheral vascular disease, n (%) | 314 (27) | 277 (24) | 315 (27) | 294 (25) | 1200 (26) |
| History of heart failure, n (%) | 538 (46) | 406 (35) | 390 (33) | 433 (37) | 1767 (38) |
| Percutaneous coronary intervention, n (%) | 212 (18) | 283 (24) | 359 (31) | 447 (38) | 1301 (28) |
| Procedure type, n (%) | |||||
| Coronary | 1070 (91) | 1069 (92) | 1057 (90) | 1032 (88) | 4228 (90) |
| Noncoronary | 99 (8) | 96 (8) | 114 (10) | 134 (11) | 0443 (9) |
| Inpatient versus outpatient, n (%) | |||||
| Inpatient | 398 (34) | 380 (33) | 307 (26) | 347 (30) | 1432 (31) |
| Outpatient | 771 (66) | 785 (67) | 864 (74) | 819 (70) | 3239 (69) |
| Total fluid duration (hr), mean (SD) | 6.9 (2.5) | 7.9 (2.5) | 8.2 (2.5) | 9.6 (3.4) | 8.1 (2.9) |
| Total fluid volume/weight (ml/kg) | |||||
| Mean (SD) | 8.8 (2.7) | 11 (1.7) | 11 (2.0) | 13 (3.0) | 11 (2.9) |
| Median (IQR) | 9.7 (7.1–11) | 11 (9.9–12) | 11 (10–12) | 13 (11–15) | 11 (9.8–12) |
| Fluid volume preprocedure (ml) | |||||
| Mean (SD) | 249 (101) | 323 (85) | 386 (100) | 537 (198) | 374 (167) |
| Median (IQR) | 248 (200–297) | 307 (277–364) | 370 (324–435) | 500 (385–630) | 343 (275–440) |
| Fluid volume during procedure (ml) | |||||
| Mean (SD) | 85 (52) | 110 (58) | 141 (75) | 201 (123) | 134 (93) |
| Median (IQR) | 75 (50–111) | 100 (70–142) | 127 (91–177) | 171 (121–248) | 115 (75–170) |
| Fluid volume postprocedure (ml) | |||||
| Mean (SD) | 367 (163) | 530 (90) | 613 (99) | 740 (160) | 563 (189) |
| Median (IQR) | 410 (300–480) | 540 (491–588) | 618 (558–677) | 729 (647–792) | 570 (472–670) |
IQR, interquartile range.
Missing percentages of left ventricular end-diastolic pressure values for each quartile: 64% in quartile 1, 71% in quartile 2, 63% in quartile 3, and 64% in quartile 4.
Primary and Secondary End Points on the Basis of Quartiles and Fluid Volume and Duration
The primary end point occurred in 265 patients (6%). In the unadjusted analysis, there was a higher incidence of the primary end point in Q1 (8%) compared with other quartiles (5% for Q2–Q4; P<0.001) (Table 2). The incidence of secondary end points, such as death by 90 days (4%; P=0.004), need for dialysis by 90 days (2%; P=0.003), and hospitalization with acute coronary syndrome, heart failure, or stroke by 90 days (13%; P<0.001) were also higher in Q1 compared with the other quartiles. The incidence of contrast-associated AKI (9% for Q1 versus 9% for Q2 versus 9% for Q3 versus 9% for Q4; P=0.95) and persistent kidney impairment by 90 days were similar across the quartiles (1% in Q1 versus 0.9% in Q2 versus 0.97% in Q3 versus 0.89% in Q4; P=0.72).
Table 2.
Primary and secondary end points on the basis of quartiles of total fluid volume administered
| End Points | Total Fluid Volume Quartiles (N=4479), n (%) | P Value | |||
|---|---|---|---|---|---|
| Quartile 1 (n=1115) |
Quartile 2 (n=1108) |
Quartile 3 (n=1130) |
Quartile 4 (n=1126) |
||
| Primary event | |||||
| Primary end pointa | 93 (8) | 57 (5) | 58 (5) | 57 (5) | 0.001b |
| Secondary end points | |||||
| Contrast-associated AKIc | 101 (9) | 97 (9) | 107 (9) | 103 (9) | 0.95 |
| Death by 90 days | 45 (4) | 24 (2) | 21 (2) | 24 (2) | 0.004b |
| Need for dialysis by 90 days | 23 (2) | 5 (0.4) | 17 (2) | 10 (0.9) | 0.003b |
| Persistent kidney impairment by 90 days | 15 (1) | 11 (0.9) | 11 (0.9) | 10 (0.8) | 0.72 |
| Hospitalization with acute coronary syndrome, heart failure, or stroke by 90 days | 145 (13) | 108 (10) | 98 (9) | 87 (8) | <0.001d |
The primary end point was a composite of death, the need for dialysis, or a persistent increase of at least 50% from baseline in the serum creatinine level at 90 days.
P<0.01.
Contrast-associated AKI was defined as an increase in serum creatinine of at least 25% or at least 0.5 mg/dl (44 µmol/L) from baseline at 3–5 days after angiography.
P<0.001.
Association between Fluid Volume (Quartiles) and Outcomes in Adjusted Models
In adjusted models, using the highest Q4 of fluid volume as the reference, there was a significantly higher risk of the primary outcome in the lowest Q1 (adjusted odds ratio [aOR], 1.58; 95% confidence interval [95% CI], 1.06 to 2.38; Table 3). There was no difference in the risk of the primary end point in Q2 and Q3 compared with Q4. There was no difference in the risk of death, need for dialysis, persistent kidney impairment by 90 days, or hospitalization with acute coronary syndrome, heart failure, or stroke by 90 days between any of the quartiles. Furthermore, the risk of contrast-associated AKI was not different in Q1, Q2, or Q3 compared with Q4. When fluid volume was analyzed as a continuous variable (per 1-ml change in fluid volume), there was no association with any of the outcomes. Cubic spline analyses failed to show a significant inflection point (Supplemental Figure 1).
Table 3.
The association between fluid volume (as quartiles) and primary and secondary outcomes
| Outcomes | Adjusted Odds Ratio (95% Confidence Interval) | |||
|---|---|---|---|---|
| Quartile 1 | Quartile 2 | Quartile 3 | Quartile 4 | |
| Primary outcome | 1.58 (1.06 to 2.38)a | 1.09 (0.72 to 1.65) | 1.22 (0.81 to 1.83) | Ref |
| Secondary outcomes | ||||
| Contrast-associated AKI | 1.09 (0.77 to 1.54) | 1.02 (0.74 to 1.41) | 1.16 (0.85 to 1.58) | Ref |
| Death by 90 days | 1.75 (0.95 to 3.22) | 1.00 (0.52 to 1.94) | 1.06 (0.55 to 2.06) | Ref |
| Need for dialysis by 90 days | 1.90 (0.80 to 4.48) | 0.59 (0.19 to 1.79) | 1.91 (0.83 to 4.40) | Ref |
| Persistent kidney impairment by 90 days | 1.48 (0.53 to 4.16) | 1.63 (0.61 to 4.34) | 1.74 (0.66 to 4.58) | Ref |
| Hospitalization with acute coronary syndrome, heart failure, or stroke by 90 days | 1.18 (0.84 to 1.65) | 1.15 (0.83 to 1.59) | 1.10 (0.79 to 1.53) | Ref |
Adjusted odds ratios and 95% confidence interval of each respective quartile versus quartile 4 at duration ≥6 hours. Adjusted for age, diabetes, eGFR, inpatient/outpatient status, history of heart failure, percutaneous coronary intervention, fluid duration, and interaction between fluid volume and fluid duration. Ref, reference.
P<0.05.
The total number of patients assessed for outcomes on the basis of duration of fluid administration were as follows: 923 patients for <6 hours and 3556 patients for ≥6 hours. The interaction between volume and duration of fluid administration for all of the outcomes was not statistically significant (P>0.05). The interaction of fluid volume and severity of CKD (eGFR <45 versus ≥45 ml/min per 1.73 m2) was not significant for all of the outcomes (Supplemental Table 1). For the PCI subgroup, the interaction was only significant for the outcome of contrast-associated AKI (P=0.02). For this outcome, the aOR comparing Q1 to Q4 was 1.68 (95% CI, 1.00 to 2.81) in the subgroup undergoing PCI and 1.06 (95% CI, 0.71 to 1.58) in the subgroup not undergoing PCI.
Discussion
The aim of this post hoc analysis was to evaluate the association of fluid volume administration with the risk of primary and secondary outcomes among participants in the PRESERVE trial and to determine whether a short duration of fluid administration <6 hours and fluid volume >1000 ml is effective prophylaxis against adverse kidney outcomes. In the PRESERVE study, participants undergoing angiography received a wide range of fluid volumes for prevention of contrast-associated AKI. In Q2–Q4 participants, who received a range of total fluid administration of 883–2790 ml, there were no differences in the risk of the primary outcome or contrast-associated AKI. However, in Q1 participants, who received a mean fluid volume of 701 ml (range, 89–882 ml), but also had the lowest eGFR and the highest prevalence of heart failure, the aOR for the primary outcome was higher compared with the reference Q4, although the risk of contrast-associated AKI was not different. There was no effect modification of a shorter duration of fluid administration (<6 versus ≥6 hours) for any of the primary or secondary outcomes.
Our study found that practice patterns with regard to prevention of contrast-associated AKI varied widely among providers. The decision on fluid volume and duration is likely determined on the basis of underlying comorbidities and risk assessments that take into consideration baseline kidney impairment and history of heart failure. The most recent ACC/American Heart Association/Society of Cardiovascular Angiography and Interventions guidelines provide no specific guidance on the amount or duration of fluid administration (13). Our findings suggest that fluid administration for a duration of 6 hours with a volume of at least 1 L has a similar association with contrast-associated AKI as longer durations and higher volumes. With this strategy, patients could potentially avoid hospitalization for prolonged fluid administration and this would facilitate outpatient angiographic procedures. However, a higher volume of fluid administered in Q4, compared with other quartiles, was not associated with a higher risk of secondary end points, including hospitalization with acute heart failure by 90 days.
Maioli et al. (20) studied the role of different volume expansion strategies and the incidence of contrast-associated AKI in patients undergoing primary percutaneous intervention. They found that lower infused volumes were associated with a significantly higher incidence of contrast-associated AKI, and the optimal cutoff point of administered volume that best discriminated patients at higher risk was ≤960 ml. In comparison to our study, baseline mean eGFR and overall incidence of contrast-associated AKI were higher in their study and the mean fluid volume administered was lower compared with the mean fluid volume in Q4 of our study. However, as in our study, the volume of fluid administration associated with improved outcomes was about 1 L.
We found a higher risk for the primary outcome in Q1 with the lowest volume of fluid administration. Although the higher risk may be due to the lower volume of fluid administered, it may also be due to residual confounding, particularly related to the severity of associated comorbidities. Participants in Q1 had a higher baseline prevalence of heart failure and lower eGFR, which may have led to administration of lower volumes of fluid. The more severe comorbidities in Q1 may have also put them at risk for the primary outcome, independent of the occurrence of contrast-associated AKI or the volume of fluid administered. Similarly, patients in Q4 had the highest prevalence of diabetes and the greatest use of PCI. Their providers may have chosen to administer higher volumes of fluid for these reasons, which may, in fact, have reduced their risk for the primary outcome or contrast-associated AKI. It is notable that, although we found a significant interaction between PCI and fluid volume for the outcome of contrast-associated AKI, none of the other outcomes had a significant interaction. This finding may be because of a lack of causal connection between AKI and the primary outcome, a spurious association related to multiple testing, or a lack of statistical power for the other outcomes. Whether using prophylactic fluid volumes >1 L in patients similar to those in Q1, with lower eGFR and a higher prevalence of heart failure, or even higher volumes in patients similar to Q4 undergoing PCI, is effective and safe can best be answered by a randomized trial. However, in the majority of patients similar to those in PRESERVE, volumes of fluid >1 L appear to prevent adverse events.
It is notable that we did not find a difference in the risk for contrast-associated AKI across the quartiles of fluid administration and, in particular, in Q1 we noted a higher risk for the primary outcome but not contrast-associated AKI. However, because we measured postangiography creatinine at only a single time point (3–5 days postprocedure), it is possible that we missed occurrences of contrast-associated AKI. Because contrast-associated AKI was ascertained in the trial using the current accepted method and as defined by Kidney Disease Improving Global Outcomes (21), it is possible the assessment of the true incidence of contrast-associated AKI was underestimated because conventional serum creatinine measurement may be an insensitive marker of kidney injury (22). However, the higher risk for the primary outcome may be due to a greater severity of underlying comorbidities and unrelated to subclinical or unrecognized AKI.
Recently, there have been several investigations that have used guided fluid administration using a variety of devices to assess hemodynamic status (14,15), rather than using a specific target fluid administration protocol. A network meta-analysis of randomized controlled trials compared tailored versus fixed volume administration strategies for prevention of contrast-associated AKI after coronary angiography and intervention (23). The tailored strategies included left ventricular end-diastolic pressure, central venous pressure, bioimpedance, and urine flow rate–guided fluid administration. Higher total volumes were associated with lower rates of contrast-associated AKI and there was no significant difference in the risk of pulmonary edema among the strategies. Overall, urine flow–guided fluid administration performed better than other hydration strategies in reducing the risk of contrast-associated AKI. Despite these positive findings, certain downsides might limit its widespread use, such as the requirement for equipment setup, which could delay procedures, risks with bladder catheter placement, and need for monitoring of electrolytes because of the higher risk of hypokalemia. The strategies using hemodynamic measurements also have the disadvantages of increased complexity of central catheter placement, risk of ectopy, and potentially increased fluoroscopy time. The results of our analysis suggest a simple protocol of administering at least 1 L of fluid for 6 hours beginning at least 1 hour before the procedure may be an easily implemented intervention for the prevention of adverse kidney events after angiography.
There are several limitations to this study. First, as previously discussed, the lack of randomized fluid volumes may be associated with residual confounding. Second, this study was limited to patients with CKD stage 3–4 undergoing angiography and excluded those with decompensated heart failure and those undergoing emergency procedures; consequently, our findings may not be generalizable to patients undergoing other types of radiographic procedures. Third, the low event rates within the groups may have reduced the power to allow us to detect small differences in the risk for study outcomes. In addition, >60% of the study population did not have left ventricular end-diastolic pressure measurements and, therefore, we were unable to incorporate that variable in the analysis.
Notwithstanding these limitations, it does add to our knowledge regarding the safe thresholds for fluid volume and duration to prevent contrast-associated AKI and longer-term adverse outcomes. Fluid volumes of at least 1 L given over 6 hours are associated with a risk of adverse kidney outcomes similar to that of higher-volume, longer-duration fluid administration. Short-duration fluid protocols will facilitate the performance of procedures, whether inpatient or outpatient, but will need to be confirmed in clinical trials including patients who are high risk.
Disclosures
S.T. Anand reports being employed by the Department of VA and Google. D.L. Bhatt reports receiving research funding from 89Bio, Abbott, Acesion, Afimmune, AkerBiomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, Contego Medical, CSI, CSL Behring, Endotronix, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, Philips, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi Aventis, Stasys, Svelte, Synaptic, The Medicines Company, and Vascular Solution; serving as site coinvestigator for Abbott, Biotronik, Boston Scientific, CSI, Endotronix, Philips, SpectraWAVE, St. Jude Medical (now Abbott), Svelte, and Vascular Solutions; serving on data monitoring committees for Acesion Pharma, Assistance Publique–Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute, and Rutgers University (for the National Institutes of Health [NIH]–funded MINT Trial); serving as trustee for the ACC; receiving honoraria from the ACC (senior associate editor of Clinical Trials and News; vice chair of ACC Accreditation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (editor in chief of Harvard Heart), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (editor in chief of Journal of Invasive Cardiology), Journal of the American College of Cardiology (guest editor and associate editor), K2P (cochair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (continuing medical education [CME] steering committees), MJH Life Sciences, Oakstone CME (course director of Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and US national coleader, funded by Bayer), Slack Publications (chief medical editor of Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (secretary/treasurer), WebMD (CME steering committees), and Wiley (steering committee); serving as deputy editor for the ACC and Clinical Cardiology, as inaugural chair of the American Heart Association Quality Oversight Committee, and as chair of the NCDR-ACTION Registry Steering Committee and VA CART Research and Publications Committee; serving on the advisory boards of AngioWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Garmin, High Enroll, Janssen, Level Ex, Medscape Cardiology, Merck, McKinsey, MyoKardia/Bristol Myers Squibb, NirvaMed, Novartis, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, and Stasys; serving on the board of directors of AngioWave, Boston VA Research Institute, Bristol Myers Squibb, DRS.LINQ, High Enroll, Society of Cardiovascular Patient Care, Stasys, and TobeSoft; having stock options in AngioWave, DRS.LINQ, and High Enroll; having consultancy agreements with Arnold and Porter Law Firm (work related to Sanofi/Bristol Myers Squibb clopidogrel litigation), Broadview Ventures, Cowen and Company (discussion of renal denervation), and Piper Sandler (discussion of data from the European Society of Cardiology Congress 2021); serving in an advisory or leadership role for Assistance Publique–Hôpitaux de Paris, Canadian Medical and Surgical Knowledge Translation Research Group, and Rutgers University; receiving royalties from Elsevier as editor of Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease; being involved with unfunded research for FlowCo and Takeda; and having a patent for sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon; neither D.L. Bhatt nor Brigham and Women’s Hospital receive any income from this patent). M.P. Gallagher reports receiving research funding from Bayer Pharmaceuticals; serving in an advisory or leadership role for Ellen Medical Devices Pty Ltd.; and having other interests in, or relationships with, The George Institute for Global Health. J.S. Kaufman reports serving as an associate editor of American Journal of Kidney Disease (paid) and as steering committee chair for ASSESS-AKI, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK; paid); having ownership interest in Amgen; having consultancy agreements with National Kidney Foundation (NKF), NIH, and Otsuka Pharmaceutical; and being employed by VA New York Harbor Healthcare System. P.M. Palevsky reports having consultancy agreements with Janssen Research & Development, LLC; serving as a member of the editorial board of the Journal of Intensive Care Medicine, president of the NKF, member of the scientific advisory board of the NKF, chair of the medical review board for Quality Insights Renal Network 4, a member of the quality, safety, and accountability committee for the Renal Physicians Association, and section editor of renal failure for UpToDate; and being employed by US Department of VA and VA Pittsburgh Healthcare System. C.R. Parikh reports having consultancy agreements with Genfit Biopharmaceutical Company; serving in an advisory or leadership role for Genfit Biopharmaceutical Company and Renalytix; receiving research funding from the National Heart, Lung and Blood Institute and NIDDK; and having ownership interest in Renalytix AI. S.D. Weisbord reports having consultancy agreements with Takeda. All remaining authors have nothing to disclose.
Funding
Supported by the US Department of VA Cooperative Studies Program grant/award CSP 578 and the National Health and Medical Research Council of Australia grant/award number APP1011387.
Supplementary Material
Acknowledgments
The contents do not represent the views of the US Department of Veterans Affairs or the US Government.
Footnotes
Published online ahead of print. Publication date available at www.cjasn.org.
Contributor Information
Collaborators: PRESERVE Trial Group, Mary Brophy, Glenn Chertow, Todd Conner, Ryan Ferguson, M. Fine, James Kaufman, Robert Lew, Peter McCullough, Paul Palevsky, Chirag Parikh, Robert Ringer, Kendrick Shunk, Susan Soliva, Steven Weisbord, Deepak Bhatt, Alan Cass, Martin Gallagher, Edward McFalls, Chirag Pirakh, Hongsheng Wu, Michelle Ratliff, Erika Ketteler, James Goff, Richard Snider, Debra Jones, Jeannie Kreuch, Claire Duvernoy, Michael Thomas, Jonathan Willatt, Hitinder Gurm, Venkat Krishnamurthy, Brahmajee Nallamothu, Kendra Szymanski, P. Michael Grossman, Daniel Menees, Patricia Rose, Kreton Mavromatis, Gautam Kumar, Sumati Raghavan, Jeanne Dow, Mahendra Mandawat, Susan Noe, Hossain Alavi, Joe Calkins, Jennifer McNear, Donald Beals, Stuart Cavalieri, Renata Sierzega, Laura Pearson, Mazhar Afaq, Paul Vaitkus, Bruce Kudryk, Dennis Hall, Neelima Nadella, William Corin, Nina Woklu, Stella Inting-Toothman, Lea Wescott, Nicole Ventura, Scott Kinlay, Kevin Croce, David Faxon, Pantel Vokonas, Joseph Raffetto, James McPhee, Naren Gupta, Adrianna Nava, Samantha Ly, Jacquelyn My-Do, Simon Ostrowski, Mariah Bundy, Margot Quinn, Melissa Chin, John Corbelli, Hasan Dosluoglu, James Lohr, Mariel Rivero, Beth Cooke, Ann Galla, Denise Cloen, Valerian Fernandes, Alexander DiBona, Christopher Nielsen, Lois Idleman, Bertha Lee, Mladen Vidovich, Melina Kibbe, Decebal Griza, Mihai Raicu, Florence Rothenberg, Charuhas Thakar, Aditi Madabhushi, Imran Arif, Jonathan Bath, Tarek Helmy, Kendra Unterbrink, Stephanie Ross, Cathy Bailey, Myrtle Hailes, Jonathan Goldberg, Joseph Jozic, Preet Kang, Jeaniene Kalman, Noah Rosenthal, Deborah Catania, Jeanne Marlow, Vinay Kumaran, Angela Krupka, Taissa Zappernick, Emmanouil Brilakis, Shirling Tsai, Subhash Banerjee, J. Gregory Modrall, Michele Roesle, Marcie Hamilton, Cassie Lusk, Jennifer Compton, Cyenthia Willis, Amy Atwell, Marilisa Soto-Gonzalez, Ajay Agarwal, Mohammad Saklayen, Donna Woerner, Jeffrey Ross, Karen Turner, Ling Zheng-Phelan, Kamia Rider, Sunil Rao, W. Schuyler Jones, Thomas Povsic, Mitchell Krucoff, James Brennan, Michael Miller, Leila Mureebe, Kathy Aristy, Marilyn Powell, Anthony Bavry, Calvin Choi, Ki Park, Tempa Curry, Debra Robertson, Cila Wright, Hani Jneid, David Paniagua, Ali Denktas, Agueda Lara-Smalling, Leah Palmer, Jo Ann Malarchick, Emily Broussard, Islam Bolad, Jeffrey Breall, Raghunandan Motaganahalli, Beth English, Jeffrey Ramkaransingh, Rita Mukerji, Roopa Subbarao, Vicki Williams, Sharon Henson, Connie Krier, Deepak Parashara, Ricardo Ciniglio, Rajat Barua, Michael Roys, Kamalakar Surineni, Kimberley Mendes, Olurinde Oni, Barry Uretsky, Zubair Ahmed, Muhammad Yousaf, Abdul Hakeem, Hui Yong Chung, Kristin Miller, Katherine Dishongh, Kodangudi Ramanathan, Rahman Shah, Jesse McGee, Zoe Qualls, Ashley Armstrong, Lillie Johnson, Santiago Garcia, Selcuk Adabag, Kairav Vakil, Jennifer Nguyen, Matthew Berg, Rebekah Herrmann, Debra Condon, Tacy Meyeraan, Steven Sedlis, Jeffrey Lorin, Mary Keary, Binita Shah, Leandro Maranan, Faisal Latif, Udho Thadani, Mazen Abu-Fadel, Jose Exaire, Talla Rousan, Arleen Ramirez-Jimenez, Trang Pham, John Giacomini, Yiming Lit, Payam Massaband, Celina Yong, William Fearon, Wei Zhou, Oliver Aalami, Theresa Peters, Karen Bratcher, Edgardo Monteverde, Aref Rahman, Rupal Bandi, Kelly Garbelotti, Suresh Mulukutla, Pamela Overberger, Suzanne Watnick, Crispin Davies, Greg Larsen, Tamara Atkinson, Jacqueline Walczyk, Tawni Kenworthy-Heinige, Stephanie Guenther, Alexandra Pitts, Ion Jovin, Anthony Minisi, Kevin Sumption, George Feldman, Jonathan Ha, Mack Hendrix, Maureen Maldonado, Deborah Jeter, Andrew Klein, Michael Forsberg, Caroline Rowe, Ammar Nasir, Kartik Mani, Paul Vercher, Kristi Waidmann, Kristin Vargo, Venkata Chilakapati, Nabil Jarmukli, Shen-Li Tan, Rathnakara Sherigar, Sharon Bottomley, Maribeth Capuno, Katherine Henley, Devasmita Dev, Jacob Mathew, Tracy Ochalek, Charles Lui, Brigham Smith, Eugene Huo, Aaron Frodsham, Noni Eskelson, Kandi Velarde, Heather Dulin, Lillian Martinez, Jeffrey Zimmet, Rajiv Sawhney, Fady Malik, Tony Chou, Cynthia Huynh, Kathleen Stanley, Epifanio Garcia, Kenneth Lehmann, Michael Stadius, Alexis Beatty, Sohilkumar Naria, Georgia Galvin, Robert Chilton, Son Pham, Rene Oliveros, Joan Hecht, Hoang Thai, Huu Tam Truong, Steven Goldman, Sergio Thal, Elizabeth Juneman, Divya Kapoor, Ryan Tsuda, Juliana Kipps, Amani Mikhail, Michael Sandoval, Jesse Currier, Hsin-Yi Lee, Donald Chang, Matthew Walsworth, Alberta Warner, Alice Chen, Dora Lendvai, Janet Johnson, Joanne Lee, Sarah Coggan, Namrata Nath Kumar, Erika Dempsey, Sradha Kotwal, Brendan Smyth, Alexia Yianni, Li Hui Lee, Siew Yan Cheong, Casey Yates, Earl James, Girish Talaulikar, Ahmad Farshid, Patricia Johnson, Pearle Taverner, Heather Chadwick, Ralph Stewart, Jocelyne Benatar, Louise Stone, Leah Howell, Sue Anderson, Siobhan Lehnhard, Cathrine Patten, Omar Farouque, Rinaldo Bellomo, Mark Horrigan, Peter Scott, Nicolas Jones, Matias Yudi, Rafi Huq, Ali Al-Fiadh, Louise Brown, David Brieger, Graham Hillis, Jonathan Cherry, Sarah Aitken, Malcom Anastasius, Jerrett Lau, Harry Lowe, Chadi Ayoub, Meg Jardine, Jody O’Connor, Christopher Wong, June Wu, Kitty Xu, Julie Webster, Liliang Mwaijele, Samantha Hand, Derek Chew, Philip Alyward, Deepu Balakrishnan, Roshan Prakash, Bhupesh Pathik, Vineet Kinatra, Dylan Jones, Arun Singh, Karim Ratib, Nassser Al Hammad, James Gunton, Jawad Mazhar, Muntaser Musameh, Catherine O’Shea, Jo Judd, Betty Raman, Fiona Wollaston, Kerri Ann Felice, Christine Hincks, Timothy Harrison, Malcolm Fawcett, Therese Wright, Lee-Anne Horsfall, Francis Kissajukian, Diedre Murphy, Pamela Bartlett, Paul Stockle, Maged William, Ihab Elsokkari, Karthikeyan Rangasamy, Probal Roy, David Tran, Muhammed Umair Hayat, Austin May, Elijah Nyakudarika, Calvin Phang, Bets Conway, Michelle O’Donoghue, Katrina Ellis, Rajesh Kanna, Randall Hendriks, Nicole Forrest, Gill Tulloch, Della Greenwell, Abd Kahar Ghapar, Abdul Raqib Abd Ghani, Shamini Sundaralingam, K. Fuah, Nor Halwani Habizal, Siti Rohaya Daud, Hafsah Begum binti Abdul Haq, Masliza Binti Mohammad, Faizah Che Hassan, Hanani Hashim, Omar Ismail, Poi Keong Kong, Soot Keng Ma, Mohamed Jahangir Abdul Wahab, Zarina Banu Abdulla, Mohamad Ali Sheikh Abdul Kader, Chong Aik Goh, Shahul Hamid Ahmadsha, Mohamad Nazrulhisham Mad Naser, Azizah Yusuf, Paramesveri Govindasamy, Nur Azliati Binti Ibrahim, Normilah Yahaya, Craig Juergens, John French, C. Mussap, Sidney Lo, S. Burgess, Trevor Mallard, Justin Huang, Manish Kumar, Adam Lee, Dominic Leung, Tamar Badie, James Xu, Andrew Terluk, Alexandria Croucher, Kelsey O’Brien, Suzanne Raynes, Maria Plotz, Hisham Hallani, Clyne Fernandes, Drew Fitzpatrick, Devang Parikh, David Coulshed, Faraz Pathan, Prashil Ganda, Pavan Chandrala, Lisa Barry, Michele Mackenzie, William VanGaal, Umair Hyat, It Men Tsay, Ivan Subiakto, Damian Cresp, Gregory Nelson, James Mau, Elizabeth Shaw, Warren Yan, Frank Arena, Edward Danson, S. Vernon, Michael Ward, U. Allahwala, Emma Reid, Nicola Straiton, Alexandra Whitley, Annie Loxton, Royal Perth Hospital: Matthew Erickson, Abdul-Rhman Ihdayid, Peter Dias, Syed Atique, Michelle Bonner, Clare Venn-Edmonds, Ananth Prasan, Mark Sader, David Ramsay, Tom Ford, James Weaver, Maurits Binnekamp, David Barrett, James Roy, Ben Ng, George Youssef, Prakriti Shrestha, Deborah Vrachas, Kate Dobinson, Ian Ternouth, Nicky Lumb, Jeffrey Sebastian, Carolyn Jackson, Cathy Vickers, Jan Prideaux, Wan Azman Wan Ahmad, Imran Zainal Abidin, Ahmad Syadi Mahmood Zuhdi, Muhammad Dzafir Ismail, Ganiga Srinivasaiah Sridhar, Soo Kun Lim, Moud Firdaus Hadi, Wan Ahmad Hafiz Wan Md Adnan, Zainab Abu Kassim, Syed Mukhtar Syed Mansor, Vin-Zhen Lee, Scott Harding, Anil Ranchord, Philip Matsis, Andrew Aitken, Mark Bernard Simmonds, Sarah Fairley, Mariusz Wolbinski, Susan Plunkett, Ali Al Sinan, Katherine Ferrier, Tim O’Meeghan, Ben Wilkins, Russell Anscomise, Alexander Sasse, Alyssa Kirby, Shakiya Ershad, Duncan Smyth, Ren Yik Lim, Diane Middleditch, and Bronwyn Davies
Author Contributions
S.T. Anand, R.E. Ferguson, and J.S. Kaufman were responsible for formal analysis; S.T. Anand, J.S. Kaufman, P.M. Palevsky, and S.D. Weisbord were responsible for methodology; R.E. Ferguson was responsible for resources; R.E. Ferguson and J.S. Kaufman provided supervision; R.E. Ferguson, J.S. Kaufman, Q.H. Soomro, and S.D. Weisbord conceptualized the study; M.P. Gallagher, P.M. Palevsky, and S.D. Weisbord were responsible for funding acquisition; M.P. Gallagher and Q.H. Soomro were responsible for data curation; Q.H. Soomro wrote the original draft; S.D. Weisbord was responsible for investigation; and all authors reviewed and edited the manuscript.
Data Sharing Statement
Anonymized data are available upon request to the VA Cooperative Studies Program Coordinating Center in Boston, MA, to investigators with an institutional review board–approved protocol.
Supplemental Material
This article contains the following supplemental material online at http://cjasn.asnjournals.org/lookup/suppl/doi:10.2215/CJN.02160222/-/DCSupplemental.
Supplemental Figure 1. Cubic spline analysis for the association of the primary outcome with fluid as a continuous variable. Harrell’s percentiles were used to place the knots (5th, 27.5th, 50th, 72.5th, and 95th percentiles).
Supplemental Table 1. Interaction analysis of fluid volume administered and eGFR or percutaneous coronary intervention and all outcomes.
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