Table 2.
Endpoints
| Endpoint | Nicotine (n = 106) |
Placebo (n = 112) |
Odds ratio, sub-hazard ratio or difference (95% CI)* | P value |
|---|---|---|---|---|
| Primary endpoint | ||||
| Day 28 mortality—no. | 30 (28%) | 31 (28%) | 1.03 (0.57–1.87) | 0.459 |
| Secondary endpoint | ||||
| Day 60 mortality† | 38/101 (38%) | 40/112 (37%) | 1.09 (0.62–1.90) | |
| Time to successful extubation, days‡ | 23 [12–31] | 27 [13–39] | 1.01 [0.74; 1.39] | |
| ICU length of stay, days | 17 [11–30] | 21 [11–30] | − 4 [− 8; 2] | |
| Hospital length of stay, days | 24 [15–42] | 28 [18–55] | − 4 [− 10; 5] | |
| Day 1–28 ventilation-free days | 0 [0–14] | 0 [0–12] | 0 [− 2; 7] | |
| Day 1–28 vasopressor-free days | 9 [0–18] | 8 [0–16] | 2 [− 6; 9] | |
| Day 1–28 renal failure-free days | 1 [0–15] | 0 [0–12] | 1 [− 3; 5] | |
| Prone position—no. | 87 (82%) | 87 (78%) | 1.32 [0.68; 2.59] | |
| iNO or prostacyclin—no. | 25 (24%) | 32 (29%) | 0.77 [0.42; 1.41] | |
| ECMO—no. (%) | 14 (13%) | 14 (13%) | 1.07 [0.40; 2.37] | |
Data are median [25th–75th percentile] or number (%)
ICU intensive care unit, iNO inhaled nitric oxide, ECMO extracorporeal membrane oxygenation
*The width of confidence intervals have not been adjusted for multiplicity and should not be used to infer definitive treatment differences
†At day 60, one patient in the nicotine group was lost to follow-up and four had withdrawn consent between day 28 and day 60
‡Treatment effect was measured with sub- Hazard ratio provided by Fine and Gray model with death and active therapies limitation as competitive events
Free-days were calculated assigning zero free-days to patients who died during the follow-up period