RecruitingPhase 2NCT06319274

Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients 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

Sponsor

Pär Johansson

Enrollment

450 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Respiratory Failure Pulmonary Infection Endothelial Dysfunction

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria8

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