Clinical trial NCT04963920: A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic Shock
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Septic Shock
Lead sponsor: CytoSorbents Europe GmbH
Sponsor class: INDUSTRY
Collaborators: name: BRAHMS GmbH
name: MedInnovation GmbH
First posted: 2021-07-15
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage change in noradrenaline (NA) dose 24 hours after baseline, assessed as mean over the time window 22 to 26 hours after baseline
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Nephrology and Medical Intensive Care, Charité - University Medical Center
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: St. Josefs Hospital - Katholisches Klinikum Bochum
city: Dresden
country: Germany
facility: Department of Anesthesiology and Critical Care Medicine, University Hospital of Dresden
city: Emden
country: Germany
facility: Klinikum Emden
city: Erfurt
country: Germany
facility: Clinic for Interdisciplinary Intensive Care and Intermediate Care, HELIOS Hospital Erfurt
city: Essen
country: Germany
facility: Department of Nephrology, University Hospital Essen
city: Frankfurt am Main
country: Germany
facility: Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy, University Hospital Frankfurt
city: Greifswald
country: Germany
facility: Department of Internal Medicine B, Cardiology, Pneumology, Infectious Diseases, Intensive Care Medicine, University Hospital Greifswald
city: Göttingen
country: Germany
facility: Department of Anesthesiology, Emergency and Intensive Care Medicine, University of Göttingen
city: Hamburg
country: Germany
facility: Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf
city: Herford
country: Germany
facility: Department of Anesthesiology, Surgical Intensive Care, Emergency and Pain Medicine, Ruhr- University Bochum, Klinikum Herford, Herford, Germany
city: Homburg
country: Germany
facility: Department of Anaesthesiology, Intensive Care and Pain Therapy, Saarland University Medical Center and Saarland University Faculty of Medicine
city: Ibbenbüren
country: Germany
facility: Department of Anesthesiology, Operative Intensive Care Medicine, Pain Management and Emergency Medicine, Hospital Ibbenbüren
city: Leipzig
country: Germany
facility: Department of Internal Medicine, Neurology and Dermatology, Interdisciplinary Internal Intensive Care Medicine, University Leipzig
city: Munich
country: Germany
facility: Department of Medicine and Polyclinic II, Hospital of University Munich
city: Munich
country: Germany
facility: Department of Internal Medicine II, Technical University of Munich
city: Munich
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine, Technical University of Munich
city: Potsdam
country: Germany
facility: Center for Emergency and Intensive Care Medicine, Hospital Ernst von Bergmann
city: Rostock
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Centre
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf (UKE)
name: Stefan Kluge, Prof
role: PRINCIPAL_INVESTIGATOR
References: