drugset / Trial / NCT04123444
Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure
Phase 2/3
Completed
279 enrolled
Jakob Stensballe, MD, PhD
Independent Research Fund Denmark · collabInnovation Fund Denmark · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in up to a total of 380 patients with septic shock suffering from organ 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 septic shock patients suffering from organ failure caused by endothelial breakdown, ultimately improving survival.
Timeline
- Start
- 2019-10-30
- Primary completion
- 2022-06-28
- Completion
- 2022-06-28
Publications
- Bestle MH, Stensballe J, Lange T, Clausen NE, Soe-Jensen P, Pedersen KH, Gybel-Brask M, Kjaer MN, Steensen CO, Jensen DB, Gartner R, Schonemann-Lund M, Kristiansen KT, Lindhardt A, Johansson PI, Perner A. Iloprost and Organ Dysfunction in Adults With Septic Shock and Endotheliopathy: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2432444. doi: 10.1001/jamanetworkopen.2024.32444.
- Bestle MH, Clausen NE, Soe-Jensen P, Kristiansen KT, Lange T, Johansson PI, Stensballe J, Perner A. Efficacy and safety of iloprost in patients with septic shock-induced endotheliopathy-Protocol for the multicenter randomized, placebo-controlled, blinded, investigator-initiated trial. Acta Anaesthesiol Scand. 2020 May;64(5):705-711. doi: 10.1111/aas.13546. Epub 2020 Feb 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iloprost | Other / unclassified | 1 unknown | Intravenous |