Clinical Trials Logo
  1. Home
  2. Septic Shock
  3. NCT06258291

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
See also
  Status Clinical Trial Phase
Recruiting NCT03649633 - Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock Phase 1/Phase 2
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Completed NCT05629780 - Temporal Changes of Lactate in CLASSIC Patients N/A
Recruiting NCT04796636 - High-dose Intravenous Vitamin C in Patients With Septic Shock Phase 1
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Recruiting NCT05066256 - LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Recruiting NCT02565251 - Volemic Resuscitation in Sepsis and Septic Shock N/A
Recruiting NCT02580240 - Administration of Hydrocortisone for the Treatment of Septic Shock N/A
Recruiting NCT02676427 - Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
Completed NCT02638545 - Hemodynamic Effects of Dexmedetomidine in Septic Shock Phase 3
Terminated NCT02335723 - ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber N/A
Not yet recruiting NCT02547467 - TOADS Study: TO Assess Death From Septic Shock. N/A
Completed NCT02204852 - Co-administration of Iloprost and Eptifibatide in Septic Shock Patients Phase 2
Completed NCT02079402 - Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Phase 4