Actively Recruiting
Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure
Led by Pär Johansson · Updated on 2025-08-22
450
Participants Needed
5
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult intensive care patients aged 18 years or older
- Suspected pulmonary infection
- Need for mechanical ventilation less than 24 hours from screening
- Soluble thrombomodulin (sTM) level 4 ng/mL or higher in blood plasma
You will not qualify if you...
- Withdrawal from active therapy
- Pregnancy or breastfeeding (confirmed by negative pregnancy test or postmenopausal status at 60 years or older)
- Septic shock with sTM level higher than 10 ng/mL
- Known allergy to iloprost or any ingredients in the treatment
- Participation in this or another prostacyclin trial within the last 30 days
- Life-threatening bleeding as determined by the treating physician
- Severe heart failure classified as NYHA class IV
- Suspected acute coronary syndrome
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Actively Recruiting
2
Dept. of Intensive Care, Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
Actively Recruiting
3
Dept. of Anaesthesia and Intensive Care, Nordsjaelands Hospital
Hillerød, Denmark, 3400
Actively Recruiting
4
Dept. of Intensive care, Hvidovre Hospital
Hvidovre, Denmark, 2650
Actively Recruiting
5
Department of Anesthesia and Intensive Care Medicine, Zealand University Hospital
Køge, Denmark, 4600
Actively Recruiting
Research Team
P
Pär I Johansson, MD, DMSc
CONTACT
K
Kristine H Pedersen, MSc. Pharm.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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