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

NCT ID: NCT06258291

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-12-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

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.

Group Type: EXPERIMENTAL

Hemosystem REBOOT

Intervention Type: DEVICE

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

Standard of care

Best standard of care will be applied to these patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hemosystem REBOOT

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

Intervention Type: DEVICE

Other Intervention Names

extracorporeal blood purification

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Written informed consent according to national requirements.

3. Hospitalized in ICU or IMC at randomization.

4. Expected length of intensive care unit stay (from randomization) >48 hours.

5. Suspected or confirmed bacterial sepsis.

6. Septic shock diagnosis at any time during ICU/IMC stay according to Sepsis - 3 criteria definition:

1. an infection (suspected or confirmed);

2. 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);

3. elevated lactate ≥ 2.0 mmol/L with suspected hypoperfusion.

7. Persistent immunosuppression defined as mHLA-DR expression levels < 5600 Ab/cell (Cyto-Chex tubes) in at least two consecutive measurements 20-72 hours apart.

Exclusion Criteria

1. 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.

2. Patient with preexisting known severe immune deficiency (e.g. severe combined immunodeficiency, HIV infection, AIDS).

3. Active or planned extracorporeal membrane oxygenation treatment.

4. Active or planned other extracorporeal blood purification treatments with systems like CytoSorb®, ToraymyxinTM, Gambro Adsorba, etc.

5. Patients post solid-organ transplantation.

6. Known active malignancy (i.e. patients under active anti-malignant treatment).

7. Acute severe burn injury > 20% of the body surface area.

8. Contraindication to use the HemoSystem:

1. Sensitivity / allergy to HemoSystem components

2. Body weight < 50 kg

3. Platelets count < 20,000/µL

4. History of heparin-induced thrombocytopenia.

9. Females who are known to be pregnant or known to be breastfeeding (b-HCG testing performed in female patients aged < 55 years),

10. Moribund patient with life expectancy < 48h

11. 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

hemotune AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joerg Schefold, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Berne, Inselspital

Locations

University Hospital Bern Inselspital

Bern, , Switzerland

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Central Contacts

Stephanie Sauter, PhD

Role: CONTACT

stephanie.sauter@hemotune.ch

+41765182096

Facility Contacts

Jan Waskowski, MD

Role: primary

Sascha David, Prof Dr

Role: primary

Other Identifiers

HNT001

Identifier Type: OTHER

Identifier Source: secondary_id

Restore I

Identifier Type: -

Identifier Source: org_study_id