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First in Human Trial to Assess the Safety of HemoSystem REBOOT in Patients With Sepsis-induced Immunosuppression — RESTORE I  

Septic Shock Clinical Trial

Official title:
A Multi-centre Randomized Controlled Trial to Assess Feasibility and Safety 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 treatment safety and the kinetics of specific biomarkers will be assessed to evaluate the selection of the treatment regimen. In a first step, 16 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 And the end of this treatment phase, it will be decided whether the dosage regimen of HemoSystem REBOOT needs to be adapted and another eight patients have to be enrolled with 2 treatments per day, and a maximum of five treatments. ;

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 October 15, 2024
Completion date October 30, 2025
View Details
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