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Compares treatment options for Acute Respiratory Failure
Official title Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure
ClinicalTrials.gov ID: NCT06319274
What this study is testing
What is Iloprost?
Iloprost is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute respiratory failure.
Also referred to as Ilomedin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Withdrawal from active therapy
- Pregnancy (non-pregnancy confirmed by patient having a negative urine- or plasma Choriogonadotropin (hCG) or being postmenopausal defined as females...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Herlev, Denmark
- Hillerød, Denmark
- Hvidovre, Denmark
- Køge, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Herlev, Denmark; Hillerød, Denmark; Hvidovre, Denmark; Køge, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.