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

NCT06258291 | Not Yet Recruiting DMC

• 2 other identifiers: Restore IHNT001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Septic Shock

Keywords

immunosuppression

Outcome Measures

Primary Outcomes (1)

• Biomarker for sepsis induced immunosuppression (monocytic HLA-DR = mHLA-DR)

  Change in mHLA-DR levels during treatment compared to the standard of care arm alone

  pre-procedure immune marker levels compared to post-treatment levels at least 24 hours after last treatment (on average estimated day 6 after treatment start)

Secondary Outcomes (9)

• To determine all-cause mortality up to 90 days follow-up

  through the end of the study (on average 90 days follow up)

• Need for organ support therapy (the number of days on organ support in the intensive care unit (index admission) defined by (1) invasive mechanical ventilation, (2) Intermittent or continuous renal replacement therapy, (3) any vasopressor support.

  until the end of the initial ICU admission (on average day 10 after initial ICU admission)

• To assess the total number of organ support free days in intensive and intermediate care unit

  until the end of the initial ICU admission (on average day 10 after initial ICU admission)

• To assess the change of Sequential Organ Failure Assessment (SOFA) score (ranging from 0 =normal to 4=significantly impaired per category)

  through the end of the study (on average 90 days follow up)

• To assess vasopressor doses during intensive and intermediate care unit stay

  until the end of the initial ICU admission (on average day 10 after initial ICU admission)

Study Arms (2)

Treatment arm

EXPERIMENTAL

The REBOOT Hemosystem will be tested in the treatment arm for a maximum of 5 treatments, the treatment will be applied in addition to standard of care alone.

Device: Hemosystem REBOOT

Standard of care

NO INTERVENTION

Best standard of care will be applied to these patients.

Interventions

Hemosystem REBOOT DEVICE

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

Also known as: extracorporeal blood purification

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Written informed consent according to national requirements.
• Hospitalized in ICU or IMC at randomization.
• Expected length of intensive care unit stay (from randomization) \>48 hours.
• Suspected or confirmed bacterial sepsis.
• Septic shock diagnosis at any time during ICU/IMC stay according to Sepsis - 3 criteria definition:
• an infection (suspected or confirmed);
• persisting hypotension requiring any dose of vasopressors (norepinephrine, vasopressin) to maintain a systemic mean blood pressure \> 65 mmHg despite adequate fluid resuscitation (minimum of 30 ml/kg crystalloids);
• elevated lactate ≥ 2.0 mmol/L with suspected hypoperfusion.
• Persistent immunosuppression defined as mHLA-DR expression levels \< 5600 Ab/cell (Cyto-Chex tubes) in at least two consecutive measurements 20-72 hours apart.

You may not qualify if:

• Current ongoing chronic treatment using immunosuppressive biologicals or active lymphocyte therapy (e.g. endoxan, rituximab) or corticosteroid use at a dose \> 10 mg/day equivalent of prednisone. However, acute treatment using a maximum dose of hydrocortisone of 200 mg/day for sepsis is allowed.
• Patient with preexisting known severe immune deficiency (e.g. severe combined immunodeficiency, HIV infection, AIDS).
• Active or planned extracorporeal membrane oxygenation treatment.
• Active or planned other extracorporeal blood purification treatments with systems like CytoSorb®, ToraymyxinTM, Gambro Adsorba, etc.
• Patients post solid-organ transplantation.
• Known active malignancy (i.e. patients under active anti-malignant treatment).
• Acute severe burn injury \> 20% of the body surface area.
• Contraindication to use the HemoSystem:
• Sensitivity / allergy to HemoSystem components
• Body weight \< 50 kg
• Platelets count \< 20,000/µL
• History of heparin-induced thrombocytopenia.
• Females who are known to be pregnant or known to be breastfeeding (b-HCG testing performed in female patients aged \< 55 years),
• Moribund patient with life expectancy \< 48h
• Known history of bleeding disorders or severe coagulopathies (e.g., Hemophilia A, Hemophilia B, Idiopathic Thrombocytopenic Purpura, Von Willebrand Disease types I, II, and III)

Sponsors & Collaborators

• hemotune AG: lead

Study Sites (2)

University Hospital Bern Inselspital

Bern, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Joerg Schefold, Prof

  University Hospital Berne, Inselspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Sauter, PhD

CONTACT

+41765182096; stephanie.sauter@hemotune.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized controlled trial: treatment in addition to standard of care versus standard of care alone

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 14, 2024
• Study Start: September 1, 2025
• Primary Completion: July 28, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)