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

Not Applicable

Recruiting

• Conditions: Septic Shock

• Registration Number: NCT04963920
• Lead Sponsor: CytoSorbents Europe GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-15
• Study Start: 2022-01-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-02
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (20)

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

St. Josefs Hospital - Katholisches Klinikum Bochum; 🇩🇪 Bochum, 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 Internal Medicine B, Cardiology, Pneumology, Infectious Diseases, Intensive Care Medicine, University Hospital Greifswald; 🇩🇪 Greifswald, Germany

Department of Anesthesiology, Emergency and Intensive Care Medicine, University of Göttingen; 🇩🇪 Göttingen, Germany

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