Efficacy and safety of 72-hour infusion of Prostacyclin (1 ng/kg/min) in mechanically ventilated patients with infectious respiratory failure

Phase 1

• Conditions: Infectious pulmonary endotheliopathy; MedDRA version: 20.0Level: LLTClassification code 10038696Term: Respiratory failure (excl neonatal)System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-004079-17-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-02
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1.Adult intensive care patients (age = 18 years)
2.Suspected pulmonary infection
3.Need for mechanical ventilation (< 24 hours from time of screening)
4.sTM = 4 ng/mL

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1.Withdrawal from active therapy
2.Pregnancy
3.Septic shock according to Sepsis-3 AND sTM>10 ng/ml
4. Known hypersensitivity to iloprost or to any of the other ingredients.
5.Previously included in this trial or a prostacyclin trial within 30 days
6.Life-threatening bleeding defined by the treating physician
7.Known severe heart failure (NYHA class IV)
8.Suspected acute coronary syndrome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to investigate whether continuous infusion of iloprost at a dose of 1 ng/kg/min for 72-hours reduces the 28-day mortality as compared to placebo.;Secondary Objective: Not applicable;Primary end point(s): 28-day all cause mortality;Timepoint(s) of evaluation of this end point: Day 28

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 90-day all cause mortality <br>Days alive and vasopressor-free days in the ICU within 28 and 90 days<br>Days alive and renal replacement free days in the ICU within 28 and 90 days<br>Days alive without mechanical ventilation in the ICU within 28 and 90 days <br>Total number and numbers of patient with one or more serious adverse reactions within the first 7 days<br>Total numbers and numbers of patients with one or more serious adverse events within the first 7 days <br>;Timepoint(s) of evaluation of this end point: Day 28 and day 90