A study to evaluate the feasibility and preliminary safety of the blood purification device HemoSystem REBOOT in critically ill patients with immune system suppression caused by sepsis.
Zusammenfassung der Studie
If the patient meets the inclusion criteria, they will be randomly assigned to one of the two groups. Randomization is important to obtain reliable results from the study. This is called randomization (it's like flipping a coin). Group 1 = the experimental group receives a maximum of 5 treatments with the blood purification device HemoSystem REBOOT plus the best standard treatment. Group 2 = the control group receives the best standard treatment alone. The study takes place at the university hospitals of Bern (Inselspital) and Zurich (USZ). Initially, eight patients will be randomly assigned to either the control group or the experimental group (with once-daily treatment). After an interim evaluation, it will be assessed whether an additional eight patients need to be included with two treatments daily (maximum 24 study participants). In this first phase, the safety and correct dosage of the treatment will be tested. Participation in the study lasts approximately 90 days. During this time, the patient will participate in a maximum of nine study visits. Appointments 1 to 7 take place in the intensive care unit, of which five visits are dedicated to treatment with the blood purification device (or corresponding observation time in the control group). The last two appointments last about 20 minutes and are conducted by phone if the patient has already been discharged from the hospital. Otherwise, appointments 8 and 9 will also take place in the hospital. During appointments 1 – 7, regular blood samples will be taken for the following study-specific determinations: Degree of immune system suppression, concentration of mediators in the blood to be removed, determination of the subtype of white blood cells, samples for the biobank.
(BASEC)
Untersuchte Intervention
The experimental group will be treated with the blood purification device HemoSystem REBOOT. The device is connected to the bloodstream via a catheter. The connection between the blood purification device and the patient is made using a tubing set. The treatment lasts two hours. During this time, the HemoSorbent (magnetic nanoparticles) is continuously injected into the tubing set via a syringe. In the tubing set, it binds to the target substances. The blood then flows through a magnetic filter in the HemoDevice, where the HemoSorbent is magnetically separated from the bound target substances. The purified blood is then returned to the body. Heparin is injected into the tubing set to prevent clotting. If the patient is undergoing renal replacement therapy, this therapy will be paused during the two-hour treatment duration. The control group receives the best standard treatment without any additional blood purification procedure during this time.
(BASEC)
Untersuchte Krankheit(en)
Sepsis is a life-threatening condition usually caused by bacterial infections, where pathogens are spread throughout the body via blood and lymph fluid. This leads to an inflammatory response with the risk of damage to internal organs. Sepsis can also cause suppression of the immune system. This makes the patient more susceptible to further infections during the illness. This, in turn, can lead to the patient needing to stay longer in the hospital and a higher risk of dying from the illness. Treatment for sepsis is typically done with antibiotics and other supportive therapies such as fluid and oxygen administration to combat the infection and stabilize the body. There is currently no targeted treatment for the suppressed immune system. HemoSystem REBOOT offers a new type of blood purification that could help strengthen patients' immune systems. The treatment removes certain mediators (Interleukin-10 (IL-10), complement factor 5a (C5a), lipopolysaccharides (LPS)) from the blood. These substances are blamed for suppressing the patient's immune system.
(BASEC)
Patients must be over 18 years old and a signed consent form from relatives must be present if the patients are unable to sign themselves. Patients must have been diagnosed with septic shock according to internationally recognized guidelines. Patients must suffer from immune system suppression with repeatedly low levels of mHLA-DR, a measure of immune system performance. (BASEC)
Ausschlusskriterien
No simultaneous treatment with immunosuppressants or lymphocytes. No contraindications to the use of the HemoSystem. Not pregnant or breastfeeding. (BASEC)
Studienstandort
Bern, Zürich
(BASEC)
Sponsor
hemotune AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Stephanie Sauter
+41765182096
stephanie.sauter@clutterhemotune.chhemotune AG Wagistrasse 27 8952 Schlieren
(BASEC)
Allgemeine Auskünfte
University Hospital Berne, Inselspital,
+41765182096
stephanie.sauter@clutterhemotune.ch(ICTRP)
Allgemeine Auskünfte
University Hospital Berne, Inselspital
+41765182096
stephanie.sauter@clutterhemotune.ch(ICTRP)
Wissenschaftliche Auskünfte
University Hospital Berne, Inselspital,
+41765182096
stephanie.sauter@clutterhemotune.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
27.09.2024
(BASEC)
ICTRP Studien-ID
NCT06258291 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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) (BASEC)
Wissenschaftlicher Titel
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) (ICTRP)
Öffentlicher Titel
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 (ICTRP)
Untersuchte Krankheit(en)
Septic Shock (ICTRP)
Untersuchte Intervention
Device: Hemosystem REBOOT (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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/L
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) (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Biomarker for sepsis induced immunosuppression (monocytic HLA-DR = mHLA-DR) (ICTRP)
To determine all-cause mortality up to 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.;To assess the total number of organ support free days in intensive and intermediate care unit;To assess the change of Sequential Organ Failure Assessment (SOFA) score (ranging from 0 =normal to 4=significantly impaired per category);To assess vasopressor doses during intensive and intermediate care unit stay;To assess the use of antimicrobial medication;To evaluate the change in the biomarker (for sepsis-induced immunosuppression) mHLA-DR concentration at various timepoints during ICU stay;To assess the technical success of in vivo target removal;Number of SADEs in treatment arm (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Joerg Schefold, Prof;Stephanie Sauter, PhD, stephanie.sauter@hemotune.ch, +41765182096, University Hospital Berne, Inselspital, (ICTRP)
Sekundäre IDs
HNT001, Restore I (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06258291 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar