protocolSection identificationModule nctId: NCT06319274, orgStudyIdInfo id: COMBAT-ARF, briefTitle: Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure, acronym: COMBAT-ARF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Pär Johansson, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Respiratory Failure, conditions: Endothelial Dysfunction, conditions: Pulmonary Infection, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomization active/placebo (1:1) parallel arms, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The preparation will be done by an unblinded study nurse independent of the including ICU´s, who will be responsible for preparing the investigational drug to be administered in a blinded fashion. Iloprost is a colorless fluid that is to be diluted in 0.9% saline. The infusion pump containing diluted active drug and placebo will be identical in both looks and behavior., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Iloprost, interventions name: Isotonic saline, outcomesModule primaryOutcomes measure: 28-day mortality, secondaryOutcomes measure: 90-day mortality, secondaryOutcomes measure: Vasopressor-free days, secondaryOutcomes measure: Renal replacement-free days, secondaryOutcomes measure: Mechanical ventilation free days, secondaryOutcomes measure: Serious adverse reactions (SARs), secondaryOutcomes measure: Serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital, city: Copenhagen, zip: 2400, country: Denmark, contacts name: Niels E Clausen, MD, role: CONTACT, contacts name: Niels E Clausen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Dept. of Intensive Care, Copenhagen University Hospital Herlev, city: Herlev, zip: 2730, country: Denmark, contacts name: Peter Soee-Jensen, MD, role: CONTACT, contacts name: Peter Soee-Jensen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.72366, lon: 12.43998, locations facility: Dept. of Anaesthesia and Intensive Care, Nordsjaelands Hospital, city: Hillerød, zip: 3400, country: Denmark, contacts name: Morten Bestle, MD, role: CONTACT, contacts name: Morten Bestle, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.92791, lon: 12.30081, locations facility: Department of Anesthesia and Intensive Care Medicine, Zealand University Hospital, city: Køge, zip: 4600, country: Denmark, contacts name: Lars Peter K Andersen, MD, PhD, role: CONTACT, contacts name: Lars Peter K Andersen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.45802, lon: 12.18214, hasResults: False