Table 1.
Patient characteristics
| Characteristic | Restrictive fluid management (n = 49) |
Usual care (n = 51) |
|---|---|---|
| Age, median [IQR], years | 71 [60–77] | 64.5 [56.2–74] |
| Male sex, n (%) | 30 (62.5) | 36 (70.6) |
| Body mass index, median [IQR], kg/m2 | 25.6 [22.8–29.5] | 26.4 [22.7–31.1] |
| Hypertension, n (%) | 26 (54.2) | 32 (65.3) |
| Diabetes, n (%) | 24 (50) | 33 (66) |
| Chronic heart failure, n (%) | 6 (12.5) | 7 (14) |
| Coronary artery disease, n (%) | 9 (18.8) | 16 (31.4) |
| Chronic obstructive pulmonary disease, n (%) | 8 (16.7) | 14 (27.5) |
| Chronic kidney disease, n (%) | 5 (10.6) | 6 (11.8) |
| Chronic liver disease, n (%) | 4 (8.3) | 3 (5.9) |
| Surgical ICU admission, n (%) | 22 (44.9) | 20 (40) |
| Emergency ICU admission, n (%) | 37 (75.5) | 41 (82) |
| Time from hospital admission to ICU admission, median [IQR], days | 1 (0.1–4) | 0.9 (0.2–2.9) |
| Time from ICU admission to randomization, median [IQR], h | 33.3 (21.4–45.9) | 30 (20.3–46) |
| Data at randomization | ||
| AKI inclusion criteria | ||
| Creatinine | 25 (51) | 28 (54.9) |
| Urine output | 10 (20.4) | 8 (15.7) |
| Creatinine and urine output | 14 (28.6) | 15 (29.4) |
| SAPS II score, median [IQR]a | 41.5 [31.3–51.5] | 43 [30–50] |
| SOFA score, median [IQR]b | 9 [8–11] | 9 [7–11] |
| AKI stage 2 to 3 (stratification), n (%) | 31 (63.3) | 33 (64.7) |
| Fluid overload present (stratification), n (%)c | 21 (42.9) | 22 (43.1) |
| Respiratory supportmechanical ventilation, n (%) | 24 (49) | 33 (66) |
| Vasoactives, n (%) | 30 (61.2) | 37 (72.5) |
| Sepsis, n (%) | 27 (55.1) | 30 (58.8) |
| Septic shock, n (%) | 5 (10.2) | 9 (17.7) |
| Cumulative fluid balance from ICU admission to randomization, mean (SD), mL | 2437 (2103) | 1982 (2434) |
The number of missing data is presented in Table S4 in the Electronic Supplementary Material
AKI acute kidney injury, SAPS simplified acute physiology score, SOFA sequential organ failure assessment
aData of one or several SAPS II score subcomponents were missing from 11 patients in the RFM group and 15 in the usual care group. Their scores are omitted here
bThe hepatic subcomponent score was assumed to be 0 in those 4 in RFM group and 3 in the control group with missing bilirubin values
cDefinition of the stratification variable: presence of peripheral pitting edema and/or positive fluid balance with P/F ratio less than 200 mmHg