Table 3.
Efficacy outcomes by treatment group
| Heparin group (n=128) | Placebo group (n=124) | Effect estimate (95% CI) | p value | |||
|---|---|---|---|---|---|---|
| Primary outcome | ||||||
| SF-36 physical function score of survivors at day 60* | 53·6 (31·6); n=97 | 48·7 (35·7); n=94 | MD 4·9 (−4·8 to 14·5) | 0·32 | ||
| Secondary outcomes | ||||||
| Day 5 | ||||||
| Developed new ARDS† | 9 (15%); n=62 | 21 (30%); n=71 | HR 0·46 (0·22 to 0·98) | 0·0431 | ||
| Deterioration in Murray Lung Injury Score‡ | −0·05 (0·49); n=124 | 0·09 (0·48); n=123 | MD −0·14 (−0·26 to −0·02) | 0·0215 | ||
| Day 28 | ||||||
| New respiratory therapies | ||||||
| Neuromuscular blocker | 16 (24%); n=67 | 18 (29%); n=63 | OR 0·78 (0·36 to 1·72) | 0·54 | ||
| Recruitment manoeuvre | 14 (12%); n=115 | 10 (9%); n=114 | OR 1·44 (0·61 to 3·39) | 0·40 | ||
| Nitric oxide or nebulised prostacyclin | 7 (6%); n=117 | 10 (9%); n=114 | OR 0·66 (0·24 to 1·80) | 0·42 | ||
| Prone positioning | 3 (2%); n=127 | 3 (2%); n=122 | OR 0·96 (0·19 to 4·85) | 0·96 | ||
| ECMO | 0 | 1 (1%) | OR 0·97 (0 to 37·78) | 0·98 | ||
| Tracheotomy | 13 (10%) | 22 (18%) | OR 0·52 (0·25 to 1·09) | 0·09 | ||
| Time to ventilator separation, days§ | 9·9 (9·8) | 10·2 (10·1); n=123 | HR 1·01 (0·77 to 1·33) | 0·92 | ||
| Time to ventilator separation of survivors, days | 6·0 (5·5); n=106 | 7·5 (7·8); n=107 | HR 1·23 (0·93 to 1·62) | 0·14 | ||
| Time to ICU separation, days§ | 11·9 (9·3) | 12·6 (9·7); n=123 | HR 1·08 (0·82 to 1·42) | 0·59 | ||
| Time to ICU separation of survivors, days | 8·5 (6·0); n=106 | 10·2 (8·1); n=107 | HR 1·31 (0·99 to 1·74) | 0·06 | ||
| ICU readmission¶ | 1 (1%); n=103 | 9 (9%); n=101 | OR 0·10 (0·01 to 0·81) | 0·0306 | ||
| Deceased | 22 (17%) | 16 (13%); n=123 | OR 1·39 (0·69 to 2·79) | 0·36 | ||
| Day 60 | ||||||
| Survivors residing at home | 86 (87%); n=99 | 73 (73%); n=100 | OR 2·45 (1·18 to 5·08) | 0·0165 | ||
| Place of residence | ||||||
| Home | 86 (70%); n=122 | 73 (62%); n=118 | OR 1·47 (0·86 to 2·52) | 0·16 | ||
| Rehabilitation | 4 (3%); n=122 | 11 (9%); n=118 | OR 0·33 (0·10 to 1·07) | 0·06 | ||
| Hospital ward | 9 (7%); n=122 | 11 (9%); n=118 | OR 0·77 (0·31 to 1·94) | 0·59 | ||
| ICU or long-term ventilation | 0; n=122 | 5 (4%); n=118 | OR 0·14 (0 to 1·04) | 0·06 | ||
| Deceased | 23 (18%); n=127 | 18 (15%); n=123 | OR 1·29 (0·66 to 2·53) | 0·46 | ||
| Day 180 | ||||||
| Survivors residing at home | 89 (94%); n=95 | 87 (93%); n=94 | OR 1·19 (0·39 to 3·69) | 0·76 | ||
| Deceased | 28 (22%); n=126 | 24 (20%); n=120 | HR 1·15 (0·67 to 1·99) | 0·61 | ||
Data are n (%) and mean (SD). The number of patients available for specific variables is stated in each cell if different from the total number of patients in the treatment group. ARDS=acute respiratory distress syndrome. ECMO=extra-corporeal membrane oxygenation. HR=hazard ratio. ICU =intensive care unit. MD=mean difference. OR=odds ratio. SF-36=Short Form-36 Health Survey.
Scores on SF-36 Health Survey Physical Function range from 0 to 100, with higher scores indicating better function.
Assessed in those ARDS-free at randomisation. ARDS development was unknown in one patient in the heparin group, who died on day 1 before ARDS assessment. There were two deaths in the heparin group and one in the placebo group by day 5. Analysed using a competing-risk approach.
Calculated by subtracting the baseline score from the highest of the scores measured daily on days 1 to 5 while mechanically ventilated. Missing data is for one in each group where ventilator separation occurred by day 1, and for three in the heparin group transferred to another ICU on day 1. Calculated without adjustment for death for the six patients in each group who were deceased by day 5.
Non-survivors to day 28 were deemed to have never had separation from either the ventilator or the ICU. There were 22 deaths in the heparin group and 16 in the placebo group. Analysed using a competing-risk approach.
Assessed in those discharged alive from ICU prior to day 28.