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

Septic Shock Clinical Trial

— PROCYSS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963920
• Other study ID #: S18
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2022
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: CytoSorbents Europe GmbH
• Contact: Antje Fechner
• Phone: +49 30 654 99 145
• Email: procyss[@]cytosorbents.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: May 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• Cytosorb® 300 ml
patients will receive CytoSorb therapy in addition to standard of care therapy according to applicable guidelines

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin	Berlin
Germany	Department of Nephrology and Medical Intensive Care, Charité - University Medical Center	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 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 Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf	Hamburg
Germany	Department of Anesthesiology, Surgical Intensive Care, Emergency and Pain Medicine, Ruhr- University Bochum, Klinikum Herford, Herford, Germany	Herford
Germany	Department of Anesthesiology, Operative Intensive Care Medicine, Pain Management and Emergency Medicine, Hospital Ibbenbüren	Ibbenbüren
Germany	Department of Internal Medicine, Neurology and Dermatology, Interdisciplinary Internal Intensive Care Medicine, University Leipzig	Leipzig
Germany	Department of Anaesthesiology and Intensive Care Medicine, Technical University of Munich	Munich
Germany	Department of Internal Medicine II, Technical University of Munich	Munich
Germany	Department of Medicine and Polyclinic II, Hospital of University 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

Sponsors (3)

Lead Sponsor	Collaborator
CytoSorbents Europe GmbH	BRAHMS GmbH, MedInnovation GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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