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

NCT04963920 | Suspended DMC

• 1 other identifier: S18
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Percentage change in noradrenaline (NA) dose 24 hours after baseline, assessed as mean over the time window 22 to 26 hours after baseline

  24 hours

Study Arms (2)

SoC+CytoSorb treatment

EXPERIMENTAL

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

Device: Cytosorb® 300 ml

Standard of Care (SoC)

NO INTERVENTION

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

Interventions

Cytosorb® 300 ml DEVICE

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

SoC+CytoSorb treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients treated with standard of care (SOC) according to guidelines for sepsis/septic shock for \> 6 and \< 30 hours prior to randomization
• 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
• Lactate \>2 mmol/l and \<8 mmol/l at baseline
• IL-6 ≥ 1000 ng/l at screening
• Minimum 18 years of age
• 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 \[Singer 2016\])

You may not qualify if:

• 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
• Administration of any other vasopressors than NA at time of randomization and within the first 28 hours after randomization
• Indication for va-ECMO at baseline OR a planned va-ECMO within the first 28 hours after randomization
• 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
• Anticipated interruption of CytoSorb® therapy for more than 2 hours within the first 26 hours after start of intervention
• 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
• Cancer patients currently on chemotherapy with cytostatics, tyrosine kinase inhibitors, or a treatment with antibodies (e.g. PD-1-inhibitors)
• Acute traumatic brain injury
• Decision to limit or withdraw treatment within the study and/or observation period in the ICU
• Pregnancy / breast feeding
• Participation in another interventional study

Sponsors & Collaborators

• CytoSorbents Europe GmbH: lead
• BRAHMS GmbH: collaborator
• MedInnovation GmbH: collaborator

Study Sites (18)

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

Hamburg, Hamburg, 20251, Germany

Location

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

Berlin, 10117, Germany

Location

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

Berlin, 12203, Germany

Location

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

Dresden, 01307, Germany

Location

Klinikum Emden

Emden, 26721, Germany

Location

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

Erfurt, 99089, Germany

Location

Department of Nephrology, University Hospital Essen

Essen, 45147, Germany

Location

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

Frankfurt am Main, 60323, Germany

Location

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

Göttingen, 37075, Germany

Location

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

Greifswald, 17475, Germany

Location

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

Herford, 32049, Germany

Location

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

Homburg, Germany

Location

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

Ibbenbueren, 49477, Germany

Location

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

Leipzig, 04103, Germany

Location

Department of Internal Medicine II, Technical University of Munich

Munich, 81675, Germany

Location

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

Munich, Germany

Location

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

Potsdam, 14467, Germany

Location

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

Rostock, 18057, Germany

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Stefan Kluge, Prof

  Universitätsklinikum Hamburg-Eppendorf (UKE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 15, 2021
• Study Start: January 30, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (18)