Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPär Johansson
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Iloprost
- Isotonic saline
Treatment groups
450 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pär Johansson
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Source ClinicalTrials.gov