Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319274
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-13
Brief Title:
Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure
Sponsor:
Pär Johansson
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Efficacy and Safety of 72-hour Infusion of Prostacyclin 1 ngkgMin in Mechanically Ventilated Patients With Infectious Pulmonary Endotheliopathy - a Multicenter Randomized Placebo-controlled Blinded Investigator-initiated Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMBAT-ARF
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
Detailed Description:
Acute respiratory failure ARF is common in critically ill patients and 50 of all intensive care unit patients require mechanical ventilation ARF occurs in a heterogenous patient group most often in the setting of pneumonia sepsis aspiration of gastric contents or severe trauma and major surgery Despite improvements in intensive care capabilities ARF mortality remains high and the only treatment option to date is supportive care A recent Cochrane analysis 2018 found no evidence for that any drug was effective in reducing deaths in mechanically ventilated patients with ARF highlighting the high unmet medical need
Given that the pulmonary system apart from the brain is the most highly vascularized vital organ in the body extensive endothelial damage is a central feature of acute respiratory distress syndrome ARDS with respiratory failure being the rationale for the current study Evidence support that iloprost infusion significantly improved endothelial function and integrity in mechanically ventilated patients with COVID-19 infection with reducing 28-day mortality by 50
The main objective in this clinical trial is to investigate whether continuous infusion of low dose iloprost at a dose of 1 ngkgmin for 72-hours is safe and significantly reduce all-cause mortality at day 28
Patients that are eligible for this trial will be temporarily incompetent due to acute severe illness relating to respiratory failure
During the trial patient will be given continuous infusion of low dose iloprost or placebo for 72 hours during their stay at the intensive care unit ICU and additional blood samples will be obtained at baseline 24- 48 and 72-hours
This trial is conducted in accordance with the Helsinki 2 Declaration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice ICH-GCP and in compliance with the protocol As part of the quality assurance on-site monitoring visit will be performed by the an independent GCP-unit including source data verification Standard Operation Procedure SOP will address protocol specific procedures
Given that the pulmonary system apart from the brain is the most highly vascularized vital organ in the body extensive endothelial damage is a central feature of acute respiratory distress syndrome ARDS with respiratory failure being the rationale for the current study Evidence support that iloprost infusion significantly improved endothelial function and integrity in mechanically ventilated patients with COVID-19 infection with reducing 28-day mortality by 50
The main objective in this clinical trial is to investigate whether continuous infusion of low dose iloprost at a dose of 1 ngkgmin for 72-hours is safe and significantly reduce all-cause mortality at day 28
Patients that are eligible for this trial will be temporarily incompetent due to acute severe illness relating to respiratory failure
During the trial patient will be given continuous infusion of low dose iloprost or placebo for 72 hours during their stay at the intensive care unit ICU and additional blood samples will be obtained at baseline 24- 48 and 72-hours
This trial is conducted in accordance with the Helsinki 2 Declaration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice ICH-GCP and in compliance with the protocol As part of the quality assurance on-site monitoring visit will be performed by the an independent GCP-unit including source data verification Standard Operation Procedure SOP will address protocol specific procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None