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

RecruitingPhase 2Ages 18 Years - anyAllPär Johansson
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Iloprost
  • Isotonic saline
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Where

5 sites
Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital
Copenhagen, Denmark
Dept. of Intensive Care, Copenhagen University Hospital Herlev
Herlev, Denmark
Dept. of Anaesthesia and Intensive Care, Nordsjaelands Hospital
Hillerød, Denmark
Dept. of Intensive care, Hvidovre Hospital
Hvidovre, Denmark
Department of Anesthesia and Intensive Care Medicine, Zealand University Hospital
Køge, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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