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Table 3 Comparisons of patients assigned to 80% and 28% fraction of inspired oxygen during 6 postoperative hours with respect to primary and secondary pre-specified and not pre-specified outcome measures

From: Postoperative Supplemental Oxygen in Liver Transplantation (PSOLT) does not reduce the rate of infections: results of a randomized controlled trial

Outcome measures

28% FiO2 (n = 99)

80% FiO2 (n = 94)

p

Primary outcome measure

 30-day postoperative infections

23 (23.2%)

32 (34.0%)

.112

 Surgical site infections

15 (15.2%)

22 (23.4%)

.200

 Urinary tract infections

4 (4.0%)

7 (7.4%)

.363

 Gastrointestinal infections

3 (3.0%)

6 (6.4%)

.321

 Pneumonia

2 (2.0%)

6 (6.4%)

.161

 Bloodstream infections

1 (1.0%)

1 (1.1%)

> .999

 Cardiovascular system infections

0 (0.0%)

1 (1.1%)

.487

 Other

0 (0.0%)

2 (2.1%)

.236

Secondary outcome measures

 90-day patient mortality rate

5 (5.1%)

4 (4.3%)

> .999

 90-day severe morbidity rate

28 (28.3%)

41 (43.6%)

.035

 Early allograft dysfunction

30 (30.3%)

36 (38.3%)

.288

 Post-transplant hospital stay (days)

17.5 (0.7)

19.1 (0.7)

.113

 Post-transplant ICU stay (days)

5.4 (0.2)

6.6 (0.4)

.033

 30-day pulmonary complication rate

25 (25.3%)

29 (30.9%)

.425

Other (not pre-specified)

 Comprehensive complication indexa

22.6 (8.7–45.7)

24.2 (12.2–48.1)

.060

 Post-reperfusion syndromeb

22 (22.2%)

30 (31.9%)

.146

 Acute kidney injuryc

46 (46.5%)

54 (57.4%)

.150

 Need for pressure support

11 (11.1%)

10 (10.6%)

> .999

  1. Data are presented and n (%) or mean (standard error)
  2. FiO2 Fraction of inspired oxygen, ICU Intensive care unit
  3. aCalculated according to Slankamenac et al. [36]
  4. bDefined as decrease in mean arterial pressure by at least 30% within 5 minutes after reperfusion lasting for at least 1 min
  5. cDefined as either increase in serum creatinine concentration by at least 0.3 mg/dL over 48 h or by at least 50% over 7 days