NCT06319274 Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure
| NCT ID | NCT06319274 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pär Johansson |
| Condition | Acute Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 450 participants in total. It began in 2024-04-15 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Pär I Johansson, MD, DMSc
STUDY DIRECTOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT06319274 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06319274 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06319274 currently recruiting?
Yes, NCT06319274 is actively recruiting participants. Contact the research team at per.johansson@regionh.dk for enrollment information.
Where is the NCT06319274 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Herlev, Denmark, Hillerød, Denmark, Hvidovre, Denmark and 1 additional location.
Who is sponsoring the NCT06319274 clinical trial?
NCT06319274 is sponsored by Pär Johansson. The principal investigator is Pär I Johansson, MD, DMSc at Rigshospitalet, Denmark. The trial plans to enroll 450 participants.