Using CytoSorb to treat vasoplegic septic shock
A Prospective, Randomized, Multicenter, Single-blind, Controlled Study to Assess the Performance of the Cytosorb® 300 ml Device for Shock Reversal in Patients With Vasoplegic Septic Shock
This study is testing if a device called CytoSorb can help patients with vasoplegic septic shock who still need medication to keep their blood pressure up, to see if it improves their recovery compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CytoSorbents Europe GmbH Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 20 sites (Berlin and 19 other locations) |
| Trial ID | NCT04963920 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the CytoSorb® 300 mL device in reversing shock in patients suffering from vasoplegic septic shock. Participants must have been treated with standard care for septic shock and still require norepinephrine to maintain blood pressure. The study aims to assess the device's performance in conjunction with existing treatment protocols to improve patient outcomes. Eligible patients will be randomized to receive either the intervention or standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are experiencing vasoplegic septic shock and have been on standard care for at least 6 hours.
Not a fit: Patients with an abdominal source of infection that has not been controlled will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery rates for patients with vasoplegic septic shock.
How similar studies have performed: While this approach is innovative, similar studies have not been extensively documented, indicating a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients treated with standard of care (SOC) according to guidelines for sepsis/septic shock for \> 6 and \< 30 hours prior to randomization 2. Vasoplegic septic shock\*, requiring NA ≥ 0.2 µg/kg/min at the time of randomization, despite adequate fluid resuscitation to maintain MAP ≥ 65 mmHg after at least 6 hours of guideline-oriented initial therapy, including continuous NA administration 3. Lactate \>2 mmol/l and \<8 mmol/l at baseline 4. IL-6 ≥ 1000 ng/l at screening 5. Minimum 18 years of age 6. Provide voluntary consent to participate in the study either directly or via a legally authorized representative (LAR) or in accordance to the procedure after determination of an emergency situation according to Art. 68 (1) MDR, as applicable * (Septic shock is defined according to the SCCM / EISCM task force Sepsis-3 definition \[Singer 2016\]) Exclusion Criteria: 1. Patients with an abdominal source of infection without a source control intervention at the time of randomization OR a planned additional surgical intervention within the first 28 hours after randomization 2. Administration of any other vasopressors than NA at time of randomization and within the first 28 hours after randomization 3. Indication for va-ECMO at baseline OR a planned va-ECMO within the first 28 hours after randomization 4. Patients with a steroid therapy above Cushing-threshold dose (e.g. 30 mg hydrocortisone/d or 6 mg prednisolone/d) for more than 30 days prior to baseline 5. Cytokine-specific antibody therapy before inclusion 6. Anticipated interruption of CytoSorb® therapy for more than 2 hours within the first 26 hours after start of intervention 7. Conditions with a poor 90-day chance of survival because of an uncorrectable medical condition such as poorly controlled neoplasm, or other moribund end-stage disease states in which death was perceived to be imminent 8. Cancer patients currently on chemotherapy with cytostatics, tyrosine kinase inhibitors, or a treatment with antibodies (e.g. PD-1-inhibitors) 9. Acute traumatic brain injury 10. Decision to limit or withdraw treatment within the study and/or observation period in the ICU 11. Pregnancy / breast feeding 12. Participation in another interventional study
Where this trial is running
Berlin and 19 other locations
- Department of Nephrology and Medical Intensive Care, Charité - University Medical Center — Berlin, Germany (Recruiting)
- Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- St. Josefs Hospital - Katholisches Klinikum Bochum — Bochum, Germany (Withdrawn)
- Department of Anesthesiology and Critical Care Medicine, University Hospital of Dresden — Dresden, Germany (Recruiting)
- Klinikum Emden — Emden, Germany (Recruiting)
- Clinic for Interdisciplinary Intensive Care and Intermediate Care, HELIOS Hospital Erfurt — Erfurt, Germany (Recruiting)
- Department of Nephrology, University Hospital Essen — Essen, Germany (Recruiting)
- Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy, University Hospital Frankfurt — Frankfurt am Main, Germany (Recruiting)
- Department of Internal Medicine B, Cardiology, Pneumology, Infectious Diseases, Intensive Care Medicine, University Hospital Greifswald — Greifswald, Germany (Recruiting)
- Department of Anesthesiology, Emergency and Intensive Care Medicine, University of Göttingen — Göttingen, Germany (Recruiting)
- Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Department of Anesthesiology, Surgical Intensive Care, Emergency and Pain Medicine, Ruhr- University Bochum, Klinikum Herford, Herford, Germany — Herford, Germany (Recruiting)
- Department of Anaesthesiology, Intensive Care and Pain Therapy, Saarland University Medical Center and Saarland University Faculty of Medicine — Homburg, Germany (Recruiting)
- Department of Anesthesiology, Operative Intensive Care Medicine, Pain Management and Emergency Medicine, Hospital Ibbenbüren — Ibbenbüren, Germany (Recruiting)
- Department of Internal Medicine, Neurology and Dermatology, Interdisciplinary Internal Intensive Care Medicine, University Leipzig — Leipzig, Germany (Recruiting)
- Department of Medicine and Polyclinic II, Hospital of University Munich — Munich, Germany (Withdrawn)
- Department of Internal Medicine II, Technical University of Munich — Munich, Germany (Recruiting)
- Department of Anaesthesiology and Intensive Care Medicine, Technical University of Munich — Munich, Germany (Recruiting)
- Center for Emergency and Intensive Care Medicine, Hospital Ernst von Bergmann — Potsdam, Germany (Recruiting)
- Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Centre — Rostock, Germany (Recruiting)
Study contacts
- Principal investigator: Stefan Kluge, Prof — Universitätsklinikum Hamburg-Eppendorf (UKE)
- Study coordinator: Antje Fechner
- Email: procyss@cytosorbents.com
- Phone: +49 30 654 99 145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.