Health TrialsbyHealthPanel

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

ConditionsAcute Respiratory FailureEndothelial DysfunctionPulmonary Infection
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Iloprost

    Drug

    Continuously infusion for 72 hours at 3 ml/hours. Treatment dose 1 ng/kg/min

  • Isotonic saline

    Drug

    Continuously infusion for 72 hours at 3 ml/hours

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: IloprostExperimental treatment 1 intervention
Group B: Isotonic salinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

28-day mortality

All-cause mortality at day 28

Time frame
Day 28

Secondary outcomes

1

90-day mortality

All-cause mortality at day 90

Time frame
Day 90
2

Vasopressor-free days

Days alive without vasopressor in the ICU within 28- and 90 days

Time frame
Until ICU discharge, maximun 90 days after randomization]
3

Renal replacement-free days

Days alive without renal replacement in the ICU within 28- and 90 days

Time frame
Until ICU discharge, maximun 90 days after randomization]
4

Mechanical ventilation free days

Days alive without mechanical ventilation in the ICU within 28- and 90 days

Time frame
Until ICU discharge, maximun 90 days after randomization]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pär Johansson

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Source ClinicalTrials.gov
Apply now