Table 3. Primary and Secondary Outcomes.
| Outcome | Study Group, Intention-to-Treat Populationa | Study Group, Per-Protocol Populationb | ||||||
|---|---|---|---|---|---|---|---|---|
| AVP Supplementation (n = 49) | Placebo (n = 51) | Analysisc | P Valued | AVP Supplementation (n = 44) | Placebo (n = 47) | Analysisc | P Valued | |
| Primary outcome | ||||||||
| 48-h Cumulative blood products, median (95% CI), L | 1.7 (0.7 to 3.1) | 3.0 (1.4 to 5.2) | Difference, −1.00 (−2.03 to 0.00) | .03 | 1.4 (0.5 to 2.6) | 2.9 (1.1 to 4.8) | Difference, −1.10 (−2.04 to 0.00) | .01 |
| Secondary outcomes | ||||||||
| 48-h Total vasopressor equivalents, median (95% CI), g | 0.6 (0.0 to 14) | 1.5 (0.2 to 14) | Difference, −0.11 (−1.35 to 0.19) | .38 | 0.4 (0.0 to 5.9) | 1.4 (0.2 to 7,6) | Difference, −0.23 (−1.37 to 0.53) | .22 |
| 48-h Crystalloid, median (95% CI), L | 9.6 (6.3 to 13) | 10 (8.6 to 15) | Difference, −1.31 (−3.43 to 0.80) | .31 | 9.9 (7.9 to 13) | 11 (8.9 to 15) | Difference, −1.07 (−3.04 to 0.62) | .22 |
| Fluid balance at 48 h, median (95% CI), L | 6.0 (3.0 to 9.2) | 7.0 (4.5 to 12) | Difference, −1.89 (−4.40 to 0.28) | .10 | 5.0 (2.5 to 7.0) | 6.7 (4.0 to 11.0) | Difference, −2.22 (−4.40 to −0.13) | .03 |
| ARDS, No. (%) | 34 (69) | 40 (78) | RR (95% CI), 0.88 (0.70 to 1.12) | .31 | 29 (66) | 36 (77) | RR (95% CI), 0.86 (0.66 to 1.12) | .27 |
| Acute kidney injury, No. (%) | 8 (16) | 14 (27) | RR (95% CI), 0.59 (0.27 to 1.29) | .19 | 2 (5) | 8 (17) | 0.27 (0.06 to 1.19) | .08 |
| Death, No. (%) | 6 (12) | 6 (12) | RR (95% CI), 1.04 (0.36 to 3.01) | .94 | NA | NA | NA | NA |
| Death in OR, No. (%) | 5 (10) | 4 (8) | RR (95% CI), 1.30 (0.37 to 4.56) | .68 | NA | NA | NA | NA |
| Open abdomen–free days, median (95% CI)e | 29 (28 to 29) | 28 (27 to 29) | HR (95% CI), 0.78 (0.46 to 1.33) | .36 | 28 (27 to 29) | 28 (26 to 29) | Difference, 0.00 (−1.00 to 1.00) | .87 |
| Time to ventilator removal, median (95% CI), d | 3 (1 to 6) | 3 (2 to 18) | HR (95% CI), 1.17 (0.79 to 1.75) | .43 | 2 (1 to 4) | 3 (1 to 12) | Difference, −1.00 (−2.00 to 0.00) | .11 |
| ICU LOS, median (95% CI), d | 5 (3 to 15) | 9 (3 to 27) | HR (95% CI), 1.26 (0.83 to 1.92) | .28 | 4 (2 to 11) | 9 (3 to 19) | Difference, −2.00 (−6.00 to 0.00) | .06 |
| Hospital LOS, median (95% CI), d | 16 (10 to 32) | 22 (14 to 44) | HR (95% CI), 1.17 (0.77 to 1.78) | .46 | 14 (10 to 25) | 20 (14 to 31) | Difference, −4.00 (−10.0 to 1.00) | .12 |
| Post hoc outcome | ||||||||
| Any complication, No (%) | 29 (59) | 34 (67) | RR (95% CI), 0.89 (0.66 to 1.20) | .44 | 24 (55) | 30 (64) | RR (95% CI), 0.85 (0.61 to 1.21) | .37 |
| DVT, No. (%) | 10 (20) | 20 (39) | RR (95% CI), 0.52 (0.27 to 1.00) | .05 | 5 (11) | 16 (34) | RR (95% CI), 0.33 (0.13 to 0.83) | .02 |
| No. of complications, median (95% CI) | NA | NA | NA | NA | 1 (1 to 2) | 2 (1 to 3) | Difference, 0 (−1 to 0) | .12 |
Abbreviations: ARDS, acute respiratory distress syndrome; HR, hazard ratio; ICU, intensive care unit; LOS, length of stay; NA, not applicable; OR, operating room; RR, relative risk.
Includes all randomized patients. Patients who died before outcome occurred were assumed to have the worst observed outcome.
Includes patients who experienced the end point. Patients who died before the end point were excluded.
Median difference in AVP vs saline groups was estimated using the Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift between groups; RR, from a logistic regression model with a log link; and HR, from a Cox proportional hazards regression model. Patients who died before event were assigned a censoring time equal to the longest observed time to outcome.
Primary and secondary analyses are each assessed at P < .05 significance criterion.
Analysis only includes patients who had an open abdomen.