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Clinical Trials in Denmark / NCT06319274
Recruiting Phase 2

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

NCT06319274 · tracked via the Priya Life Science Denmark tracker
Sponsor
Pär Johansson
Phase
Phase 2
Started
2024-04-15
Last updated
2025-08-22

Condition(s) studied

Acute Respiratory FailureEndothelial DysfunctionPulmonary Infection

Investigational drug(s) / intervention(s)

Iloprost →Isotonic saline

Iloprost: Continuously infusion for 72 hours at 3 ml/hours. Treatment dose 1 ng/kg/min

Isotonic saline: Continuously infusion for 72 hours at 3 ml/hours

Study summary

The purpose of this clinical trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 450 mechanically ventilated patients with infectious respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult intensive care patients (age ≥ 18 years) * Suspected pulmonary infection * Need for mechanical ventilation (\< 24 hours from time of screening) * soluble thrombomodulin (sTM) ≥ 4 ng/mL in blood plasma Exclusion Criteria: * Withdrawal from active therapy * Pregnancy (non-pregnancy confirmed by patient having a negative urine- or plasma Choriogonadotropin (hCG) or being postmenopausal defined as females at 60 years old or beyond or at the investigators discretion) * Septic shock according to the Sepsis 3 criteria AND a sTM\> 10 ng/ml * Known hypersensitivity to iloprost or to any of the other ingredients. * Previously included in this trial or a prostacyclin trial within 30 days * Life-threatening bleeding defined by the treating physician * Known severe heart failure (NYHA class IV) * Suspected acute coronary syndrome

Primary outcome measure(s)

  • 28-day mortality — Day 28
    All-cause mortality at day 28

Trial sites (5)

FacilityCityRegionStatus
Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital Copenhagen Denmark Recruiting
Dept. of Intensive Care, Copenhagen University Hospital Herlev Herlev Denmark Recruiting
Dept. of Anaesthesia and Intensive Care, Nordsjaelands Hospital Hillerød Denmark Recruiting
Dept. of Intensive care, Hvidovre Hospital Hvidovre Denmark Recruiting
Department of Anesthesia and Intensive Care Medicine, Zealand University Hospital Køge Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06319274 on ClinicalTrials.gov ↗ ← All trials in Denmark