Table 3.
Schedule of events
| Event | Time of presentation until first dose (screen/baseline) | First dose until end of that calendar day (Day 1) | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | 7 days after last dose | Hospital discharge or study Day 28, whichever comes first | 6 months | 12 months |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Informed consent | X | |||||||||||
| Inclusion/exclusion criteria | X | |||||||||||
| Pregnancy test in women of childbearing potential | X | |||||||||||
| Demographics | X | |||||||||||
| Medical history | X | |||||||||||
| LIPS score | X | |||||||||||
| Randomisation | X | |||||||||||
| Study drug administration | X | X | X | X | X | X | X | |||||
| Clinical outcome assessment | X | X | X | X | X | X | X | X | ||||
| Safety labs: Cr and Hb | X | X | X | X | X | X | X | |||||
| Clinical data as available: labs, ABG | X | X | X | X | X | X | X | X | ||||
| CXR/ABG* | X | X | X | X | X | X | X | |||||
| CLIP | X | X | X | X | X | X | X | X | ||||
| AE/SAE monitoring | X | X | X | X | X | X | X | X | X | |||
| Survival | X | X | ||||||||||
| Plasma biomarkers of ALI | X | X | X | |||||||||
| SF-12 | X | X | X | |||||||||
| Barthel Index | X | X | X | |||||||||
| Vulnerable Elders Survey | X | X | X | |||||||||
| Brussels/SOFA composite | X |
*Chest x-ray (CXR) required on days 1–7 ONLY IF patient is intubated, and DOES NOT have ALI/ARDS already, AND there is clinical evidence of worsening respiratory status defined as:
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▪▪ Previous P/F ratio≥300, with current P/F ratio<300 and no CXR within 24 h.
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▪▪ Prior P/F ratio<300 and the P/F ratio has fallen more than 10% AND no CXR within 24 h.
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▪▪ In cases where an ABG is not available, the research team should obtain an ABG only if the S/F ratio falls below 315 consistently. The P/F ratio obtained from that ABG will be used to determine whether a CXR needs to be obtained (as per criteria outlined above).
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▪▪ If change in P/F ratio triggers the need for a CXR or ABG as above, sites have 24 h to conduct the necessary procedure. An ABG or CXR obtained by the clinical team during that time period is also acceptable and obviates the need to obtain said procedure for the research study.
ABG, arterial blood gas; AE, adverse events; ALI, acute lung injury; ARDS, acute respiratory distress syndrome; CLIP, checklist for lung injury prevention; Cr, creatinine; Hb, haemoglobin; LIPS, Lung Injury Prevention Study; LIS, lung injury severity score; SAE, serious adverse events; SF-12, 12-Item Short-Form Health Survey; SOFA, sequential organ failure assessment.