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First in Human Trial to Assess the Safety & Efficacy of HemoSystem REBOOT in Patients With Sepsis-induced Immunosuppression — (RESTORE)  

Septic Shock Clinical Trial

Official title:
A Multi-centre Randomized Controlled Trial to Assess Safety and Efficacy of Adjunctive Treatment With the HemoSystem REBOOT in Critically Ill patientS wiTh Sepsis-induced Immunosuppression

Clinical Trial Summary

The aim of this randomized controlled trial is to restore immune function by selectively removing three mediators largely contributing to sepsis-induced immunosuppression from extracorporeal circulation.

Clinical Trial Description

The study will be divided in two phases: I) Safety and Dose Selection Phase Within a first safety and dose selection phase, the treatment safety and the kinetics of specific biomarkers will be assessed to evaluate the selection of the treatment regimen. In a first step the patients will be randomized 1:1 into two arms: Treatment arm 1: One treatment of 2 hours per day for a maximum of five days or until ICU discharge or death or withdrawal of consent, whichever occurs first. Control arm: Five consecutive days following the first mHLA-DR measurement post study randomization, or until ICU discharge or death or withdrawal of consent, whichever occurs first After confirmation of the safety by an independent DSMB; the study will move into the efficacy phase. II) Efficacy phase Unless the study is stopped for safety reasons, at least 106 patients will be randomized 1:1 into a control arm or the selected treatment arm. An pre-defined interim analysis will be conducted when at least 28 patients in each treatment arm have completed the initial treatment phase. The interim analysis will also include a sample size re-estimation. The results will be reviewed by the independent DSMB, which will make recommendations about safety, early stopping for futility, and sample size re-estimation (which means an increase of the sample size to 180 patients). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06258291
Study type Interventional
Source hemotune AG
Contact Stephanie Sauter, PhD
Phone +41765182096
Email stephanie.sauter@hemotune.ch
Status Not yet recruiting
Phase N/A
Start date September 15, 2024
Completion date June 30, 2026
View Details
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