Efficacy and Safety of 72-hour Infusion of Prostacyclin (1 ng/kg/min) in Mechanically Ventilated Patients With Infectious Pulmonary Endotheliopathy - Multicenter Randomized, Placebo-Controlled, Blinded Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a continuous intravenous low dose of iloprost compared to placebo over 72 hours in 450 mechanically ventilated patients with infectious respiratory failure. This trial focuses on patients suffering from acute respiratory failure due to endothelial breakdown in the lungs, aiming to see if iloprost can help restore vascular integrity and improve survival. The study is a phase 2, randomized, placebo-controlled trial conducted under strict international standards for clinical research. Participants will receive either a continuous infusion of iloprost at 1 ng/kg/min or a placebo infusion for up to 72 hours while in the intensive care unit (ICU). Treatment will continue until 72 hours have passed, or the patient is discharged to the ward or dies, whichever occurs first. Blood samples will be collected at baseline and at 24, 48, and 72 hours to monitor effects and safety. The study includes two groups: 225 patients receiving iloprost and 225 receiving placebo. During the study, patients will be closely monitored in the ICU with assessments including survival status at 28 days, plus secondary outcomes such as survival at 90 days, days free from vasopressors, renal replacement, and mechanical ventilation. Serious adverse events and reactions will be tracked until 7 days after treatment starts. The total participation time varies depending on ICU discharge and survival, with rigorous quality assurance and data verification procedures in place.

Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure