Table 2. Main Outcomes of the Study of Resuscitation Strategies in Septic Shock.
| Outcome | Peripheral Perfusion–Targeted Resuscitation (n = 212) |
Lactate Level–Targeted Resuscitation (n = 212) |
Unadjusted Absolute Difference (95% CI) | Adjusted Relative Measure (95% CI) | P Value |
|---|---|---|---|---|---|
| Primary Outcome | |||||
| Death within 28 d, No. (%) | 74 (34.9) | 92 (43.4) | −8.5 (−18.2 to 1.2)b | HR, 0.75 (0.55 to 1.02)a | .06a |
| Secondary Outcomes | |||||
| Death within 90 d, No. (%) | 87 (41.0) | 99 (46.7) | −5.7 (−15.6 to 4.2)b | HR, 0.82 (0.61 to 1.09)a | .17a |
| Mechanical ventilation–free days within 28 d, mean (SD)c | 14.6 (12.1) | 12.7 (12.2) | 1.9 (−0.6 to 4.3) | .14 | |
| Renal replacement therapy–free days within 28 d, mean (SD)c | 18.5 (12.1) | 16.9 (12.1) | 1.7 (−1.5 to 4.8) | .31 | |
| Vasopressor-free days within 28 d, mean (SD)c | 16.7 (12.0) | 15.1 (12.3) | 1.6 (−0.7 to 3.9) | .18 | |
| SOFA at 72 h, No.d | 165 | 166 | .045 | ||
| Mean (SD) | 5.6 (4.3) | 6.6 (4.7) | −1.00 (−1.97 to −0.02) | ||
| ICU length of stay, mean (SD), de | 9.1 (9.8) | 9.0 (9.6) | 0.1 (−1.7 to 2.0) | .91 | |
| Hospital length of stay, mean (SD), df | 22.9 (28.8) | 18.3 (19.0) | 4.6 (0.0 to 9.1) | .05 | |
| Exploratory Outcomes | |||||
| Amount of resuscitation fluids within the first 8 h, No. | 206 | 209 | |||
| Mean (SD), mL | 2359 (1344) | 2767 (1749) | −408 (−705 to −110) | .01 | |
| Total fluid balance, mLg | |||||
| Within 8 h, No. | 198 | 205 | |||
| Mean (SD) | 1587 (1388) | 1874 (1756) | −288 (−598 to 22.0) | .07 | |
| Within 24 h, No. | 176 | 185 | |||
| Mean (SD) | 2025 (2181) | 2343 (2336) | −318 (−785 to 149) | .18 | |
| Within 48 h, No. | 153 | 160 | |||
| Mean (SD) | 992 (1810) | 1224 (3336) | −233 (−831 to 366) | .45 | |
| Within 72 h, No. | 157 | 162 | |||
| Mean (SD) | 1389 (2809) | 1601 (3069) | −212 (−858 to 434) | .52 | |
| Intra-abdominal hypertension, No. of events/total (%)h | 75/119 (63.0) | 68/120 (56.7) | 6.4 (−6.9 to 19.6) | RR, 1.11 (0.90 to 1.37) | .36i |
| Use of renal replacement therapy, No. (%) | 30 (14.2) | 42 (19.8) | −5.7 (−13.3 to 1.9) | RR, 0.71 (0.47 to 1.10) | .15i |
| In-hospital mortality, No. (%) | 84 (39.6) | 97 (45.8) | −6.1 (−16.0 to 3.7) | RR, 0.87 (0.69 to 1.08) | .20i |
Abbreviations: HR, hazard ratio; ICU, intensive care unit; RR, risk ratio; SOFA, Sequential Organ Failure Assessment.
Hazard ratio (95% CI) and P value calculated with Cox proportional hazards model with adjustment for baseline values of Acute Physiology and Chronic Health Evaluation II score, SOFA score, lactate levels, capillary refill time, and source of infection.
Absolute difference (95% CI) calculated from Cox proportional hazard model without adjustment for covariates.
Treatment effects on mechanical ventilation, renal replacement therapy, and vasopressor use assessed with zero inflated negative binomial models.
Treatment effect calculated with linear regression adjusting for baseline SOFA score.
Treatment effects on ICU stay, hospital stay, and resuscitation fluids assessed with generalized linear models with gamma distribution.
Patients still in the hospital for 90 days or more after randomization were considered to be discharged alive at day 90.
Fluid balance within 8, 24, and 72 hours was calculated as all intravenous fluids minus urine output and gastrointestinal losses from randomization to the specified time point. Treatment effect on total fluid balance was calculated with linear regression.
Defined as an intra-abdominal pressure equal or higher than 12 mm Hg. Intra-abdominal pressure was measured via the bladder, with instillation of 25 mL of sterile saline at end-expiration in the complete supine position, with transducer zeroed at the level of the mid-axillary line.
From Fisher exact test.