A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic Shock

NCT ID: NCT04963920

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-30
• Study Completion Date: 2027-05-31

Brief Summary

To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SoC+CytoSorb treatment

patients allocated to this group, will receive CytoSorb therapy in addition to the standard of care therapy according to applicable guidelines

Group Type: EXPERIMENTAL

Cytosorb® 300 ml

Intervention Type: DEVICE

patients will receive CytoSorb therapy in addition to standard of care therapy according to applicable guidelines

Standard of Care (SoC)

patients allocated to this group will receive only standard of care therapy according to applicable guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cytosorb® 300 ml

patients will receive CytoSorb therapy in addition to standard of care therapy according to applicable guidelines

Intervention Type: DEVICE

Eligibility 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

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

Sponsors

BRAHMS GmbH

UNKNOWN

Sponsor Role: collaborator

MedInnovation GmbH

INDUSTRY

Sponsor Role: collaborator

CytoSorbents Europe GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Kluge, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf (UKE)

Locations

Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

Department of Nephrology and Medical Intensive Care, Charité - University Medical Center

Berlin, , Germany

Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin

Berlin, , Germany

Department of Anesthesiology and Critical Care Medicine, University Hospital of Dresden

Dresden, , Germany

Klinikum Emden

Emden, , Germany

Clinic for Interdisciplinary Intensive Care and Intermediate Care, HELIOS Hospital Erfurt

Erfurt, , Germany

Department of Nephrology, University Hospital Essen

Essen, , Germany

Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy, University Hospital Frankfurt

Frankfurt am Main, , Germany

Department of Anesthesiology, Emergency and Intensive Care Medicine, University of Göttingen

Göttingen, , Germany

Department of Internal Medicine B, Cardiology, Pneumology, Infectious Diseases, Intensive Care Medicine, University Hospital Greifswald

Greifswald, , Germany

Department of Anesthesiology, Surgical Intensive Care, Emergency and Pain Medicine, Ruhr- University Bochum, Klinikum Herford, Herford, Germany

Herford, , Germany

Department of Anaesthesiology, Intensive Care and Pain Therapy, Saarland University Medical Center and Saarland University Faculty of Medicine

Homburg, , Germany

Department of Anesthesiology, Operative Intensive Care Medicine, Pain Management and Emergency Medicine, Hospital Ibbenbüren

Ibbenbueren, , Germany

Department of Internal Medicine, Neurology and Dermatology, Interdisciplinary Internal Intensive Care Medicine, University Leipzig

Leipzig, , Germany

Department of Internal Medicine II, Technical University of Munich

Munich, , Germany

Department of Anaesthesiology and Intensive Care Medicine, Technical University of Munich

Munich, , Germany

Center for Emergency and Intensive Care Medicine, Hospital Ernst von Bergmann

Potsdam, , Germany

Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Centre

Rostock, , Germany

Countries

Germany

Other Identifiers

S18

Identifier Type: -

Identifier Source: org_study_id