NCT06258291

First in Human Trial to Assess the Feasibility and Preliminary Safety of Adjunctive Treatment with the HemoSystem REBOOT in Critically Ill Patients with Sepsis-induced Immunosuppression

A Multi-center Randomized Controlled First in Human Trial to Assess the Feasibility and Preliminary Safety Data of Adjunctive Treatment with the HemoSystem REBOOT in Critically Ill PatientS with Sepsis-induced ImmunOsuppREssion (RESTORE I)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: hemotune AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DEVICE	Hemosystem REBOOT	The HemoSystem REBOOT will selectively remove three mediators largely contributing to sepsis-induced immunosuppression, from extracorporeal circulation based on magnetic beads.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-07-28
• Completion: 2026-12-30
• First posted: 2024-02-14
• Last updated: 2025-03-14

Locations

2 sites across 1 country: Switzerland