Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Acute Respiratory Failure, Endothelial Dysfunction, Pulmonary Infection
In brief
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.
Key facts
- Study ID
- NCT06319274
- Run by
- Pär Johansson
- People needed
- 450
- Starts
- 2024-04-15
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital — Copenhagen, Denmark (enrolling)
- Dept. of Intensive Care, Copenhagen University Hospital Herlev — Herlev, Denmark (enrolling)
- Dept. of Anaesthesia and Intensive Care, Nordsjaelands Hospital — Hillerød, Denmark (enrolling)
- Dept. of Intensive care, Hvidovre Hospital — Hvidovre, Denmark (enrolling)
- Department of Anesthesia and Intensive Care Medicine, Zealand University Hospital — Køge, Denmark (enrolling)
Full record on ClinicalTrials.gov
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