Respiratory failure & ventilation
Efficacy and safety of a 72‐h infusion of prostacyclin (1 ng/kg/min) in mechanically ventilated patients with pulmonary infection and endotheliopathy—protocol for the multicenter randomized, placebo‐controlled, blinded, investigator‐initiated COMBAT ‐ acute respiratory failure (ARF) trial
Study context
- Population
- Mechanically ventilated patients with suspected pulmonary infection and severe endotheliopathy (soluble thrombomodulin (sTM) ≥4 ng/mL)planned enrolment
- Participants
- 450 participants
- Planned comparison
- 72-h infusion of low-dose prostacyclin 1 ng/kg/min vs placebo
- Primary endpoint
- All-cause mortality
- Follow-up
- 28 days
Methodological detailsmulticentre, placebo-controlled, blinded, investigator-initiated, phase 3, Randomised 1:1, Secondary endpoints: 90-day mortality; days alive without vasopressor, mechanical ventilation and RRT in the ICU within 28 and 90 days; serious adverse reactions or serious adverse events within the first 7 days
- Multicentre
- Placebo-controlled
- Blinded
- Investigator-initiated
- Phase 3
- Randomised 1:1
- Secondary endpoints: 90-day mortality; days alive without vasopressor, mechanical ventilation and RRT in the ICU within 28 and 90 days; serious adverse reactions or serious adverse events within the first 7 days
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Efficacy and safety of a 72‐h infusion of prostacyclin (1 ng/kg/min) in mechanically ventilated patients with pulmonary infection and endotheliopathy—protocol for the multicenter randomized, placebo‐controlled, blinded, investigator‐initiated COMBAT ‐ ARF trial. Acta Anaesthesiol Scand. Published 20 December 2024. doi:10.
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