Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure

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

Outcome

Missed primary endpoint

paper The mean [IQR] daily SOFA score was 10.6 (6.4-14.8) in the iloprost group and 10.5 (5.9-15.5) in the placebo group (adjusted mean difference, 0.2 [95% CI, -0.8 to 1.2]; P = .70). PMID 39259541 ↗

paper infusion of iloprost, 1 ng/kg/min, for 72 hours did not reduce mean daily SOFA scores compared with placebo. PMID 39259541 ↗

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

Indications