Septic ShockRESTORE INCT06258291
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 study testing Hemosystem REBOOT in people with Septic Shock, run by hemotune AG at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Hemosystem REBOOT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Sep 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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).
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- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites
University Hospital Bern Inselspital
Bern
Jan Waskowski, MD
University Hospital Zurich
Zurich
Sascha David, Prof Dr
About this study
Official title: 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)
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.
Read the 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
- Being tested
- Hemosystem REBOOT
- Keywords
- immunosuppression
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemosystem REBOOTDevice
Also called extracorporeal blood purification
The HemoSystem REBOOT will selectively remove three mediators largely contributing to sepsis-induced immunosuppression, from extracorporeal circulation based on magnetic beads.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hemosystem REBOOT |
| Standard of care | No intervention | Best standard of care will be applied to these patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Difference in mortality between treatment arm and standard of care arm
Measured: 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.
Difference between treatment arm and standard of care arm
Measured: 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
Difference in total number of organ support free days between treatment arm and standard of care arm
Measured: 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)
Difference in SOFA score between treatment arm and standard of care arm
Measured: through the end of the study (on average 90 days follow up)
To assess vasopressor doses during intensive and intermediate care unit stay
To assess the difference in dosing between the treatment arm and standard of care arm
Measured: until the end of the initial ICU admission (on average day 10 after initial ICU admission)
To assess the use of antimicrobial medication
Difference in days on antimicrobials vs days off antimicrobials between treatment arm and standard of care arm
Measured: through the end of the study (on average 90 days follow up)
To evaluate the change in the biomarker (for sepsis-induced immunosuppression) mHLA-DR concentration at various timepoints during ICU stay
Difference in immune markers between treatment arm and standard of care arm will be compared
Measured: at admission to ICU, on the day of first, 2nd, 3rd, 4th, and 5th treatment, and daily up to 72 hours after last treatment.
To assess the technical success of in vivo target removal
Technical success rate in treatment arm
Measured: immediately after last treatment
Number of SADEs in treatment arm
SADE rate
Measured: through the end of the study (on average 90 days follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Sep 2025 (estimated)
- Primary completion28 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial: treatment in addition to standard of care versus standard of care alone
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- hemotune AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joerg Schefold, Prof, Principal investigator, University Hospital Berne, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258291
- Sponsor's protocol ID
- Restore I
- Other IDs
- HNT001
- Acronym
- RESTORE I
- Status last verified
- Mar 2025
- First submitted
- 12 Jan 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06258291
- Acronym / sponsor ID
- RESTORE I / Restore I
- Conditions
- Septic Shock
- Keywords
- immunosuppression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- hemotune AGIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 28 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial: treatment in addition to standard of care versus standard of care alone
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Hemosystem REBOOTThe 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. |
| Standard of care | No intervention | –Best standard of care will be applied to these patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemosystem REBOOTAlso: extracorporeal blood purificationThe HemoSystem REBOOT will selectively remove three mediators largely contributing to sepsis-induced immunosuppression, from extracorporeal circulation based on magnetic beads. | Device | Treatment arm |
Primary outcome
Biomarker for sepsis induced immunosuppression (monocytic HLA-DR = mHLA-DR)
Time frame: 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)
Change in mHLA-DR levels during treatment compared to the standard of care arm alone
9 secondary outcomes
To determine all-cause mortality up to 90 days follow-up
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: through the end of the study (on average 90 days follow up)
To assess vasopressor doses during intensive and intermediate care unit stay
Time frame: until the end of the initial ICU admission (on average day 10 after initial ICU admission)
To assess the use of antimicrobial medication
Time frame: through the end of the study (on average 90 days follow up)
To evaluate the change in the biomarker (for sepsis-induced immunosuppression) mHLA-DR concentration at various timepoints during ICU stay
Time frame: at admission to ICU, on the day of first, 2nd, 3rd, 4th, and 5th treatment, and daily up to 72 hours after last treatment.
To assess the technical success of in vivo target removal
Time frame: immediately after last treatment
Number of SADEs in treatment arm
Time frame: through the end of the study (on average 90 days follow up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joerg Schefold, Prof principal investigator
University Hospital Berne, Inselspital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemosystem REBOOT in people with Septic Shock, run by hemotune AG at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Sauter, PhD (+41765182096, stephanie.sauter@hemotune.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker for sepsis induced immunosuppression (monocytic HLA-DR = mHLA-DR) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.