Infusion of iloprost for 72 hours in patients on mechanical ventilation with acute respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.