Infusion of iloprost for 72 hours in patients on mechanical ventilation with acute respiratory failure
Efficacy and Safety of 72-hour Infusion of Prostacyclin (1 ng/kg/Min) in Mechanically Ventilated Patients With Infectious Pulmonary Endotheliopathy - a Multicenter Randomized, Placebo-controlled, Blinded, Investigator-initiated Trial
This study is testing if giving a medication called iloprost for 72 hours can help patients on mechanical ventilation with severe breathing problems caused by infections feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 5 sites (Copenhagen and 4 other locations) |
| Trial ID | NCT06319274 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of continuous intravenous administration of low-dose iloprost compared to a placebo in 450 mechanically ventilated patients suffering from acute respiratory failure due to infectious causes. The study aims to determine if iloprost can improve endothelial function and reduce all-cause mortality at day 28 by restoring vascular integrity in patients with significant endothelial damage. Eligible patients will be those requiring mechanical ventilation and exhibiting specific biomarkers indicative of endothelial dysfunction. The trial will last for 72 hours, during which patients will receive either iloprost or isotonic saline.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older who are mechanically ventilated due to suspected pulmonary infections.
Not a fit: Patients with septic shock, severe heart failure, or those who have previously participated in similar trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality rates in critically ill patients with acute respiratory failure.
How similar studies have performed: Previous studies have shown promising results with iloprost in improving endothelial function in similar patient populations, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen and 4 other locations
- 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)
Study contacts
- Principal investigator: Peter Soee-Jensen, MD — +4538682458
- Study coordinator: Pär I Johansson, MD, DMSc
- Email: per.johansson@regionh.dk
- Phone: +4535452030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.