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

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

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

Study Overview

• Status: Recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Device: Cytosorb® 300 ml

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Christin Pawlik, PhD; Phone Number: +49 30 654 99 145; Email: clinical@cytosorbents.com
• Study Contact Backup: Name: Antje Fechner; Phone Number: +49 30 654 99 145; Email: clinical@cytosorbents.com

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
    • Principal Investigator: Sascha Treskatsch, MD, Prof
  • Berlin, Germany, 10117
    • Recruiting
    • Department of Nephrology and Medical Intensive Care, Charité - University Medical Center
    • Principal Investigator: Philipp Enghard, MD, PD
  • Bochum, Germany, 44791
    • Recruiting
    • St. Josefs Hospital - Katholisches Klinikum Bochum
    • Principal Investigator: Martin Bellgardt, MD
  • Dresden, Germany, 01307
    • Recruiting
    • Department of Anesthesiology and Critical Care Medicine, University Hospital of Dresden
    • Principal Investigator: Peter Spieth, MD, Prof
  • Emden, Germany, 26721
    • Recruiting
    • Klinikum Emden
    • Principal Investigator: Matthias Drüner, MD
  • Erfurt, Germany, 99089
    • Recruiting
    • Clinic for Interdisciplinary Intensive Care and Intermediate Care, HELIOS Hospital Erfurt
    • Principal Investigator: Heinrich Groesdonk, MD, Prof
  • Essen, Germany, 45147
    • Recruiting
    • Department of Nephrology, University Hospital Essen
    • Principal Investigator: Justa Friebus-Kardash, MD
  • Frankfurt am Main, Germany, 60323
    • Recruiting
    • Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy, University Hospital Frankfurt
    • Principal Investigator: Kai Zacharowski, MD, Prof
  • Greifswald, Germany, 17475
    • Recruiting
    • Department of Internal Medicine B, Cardiology, Pneumology, Infectious Diseases, Intensive Care Medicine, University Hospital Greifswald
    • Principal Investigator: Sigrun Friesecke, MD, PD
  • Göttingen, Germany, 37075
    • Recruiting
    • Department of Anesthesiology, Emergency and Intensive Care Medicine, University of Göttingen
    • Principal Investigator: Onnen Moerer, MD, Prof
  • Hamburg, Germany, 20251
    • Recruiting
    • Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf
    • Principal Investigator: Stefan Kluge, MD, Prof
  • Herford, Germany, 32049
    • Recruiting
    • Department of Anesthesiology, Surgical Intensive Care, Emergency and Pain Medicine, Ruhr- University Bochum, Klinikum Herford, Herford, Germany
    • Principal Investigator: Dietrich Henzler, MD, Prof
  • Ibbenbüren, Germany, 49477
    • Recruiting
    • Department of Anesthesiology, Operative Intensive Care Medicine, Pain Management and Emergency Medicine, Hospital Ibbenbüren
    • Principal Investigator: Stephan Ziegeler, MD, PD
  • Leipzig, Germany, 04103
    • Recruiting
    • Department of Internal Medicine, Neurology and Dermatology, Interdisciplinary Internal Intensive Care Medicine, University Leipzig
    • Principal Investigator: Sirak Petros, MD, Prof
  • Munich, Germany, 81377
    • Recruiting
    • Department of Medicine and Polyclinic II, Hospital of University Munich
    • Principal Investigator: Stephanie-Susanne Stecher, MD
  • Munich, Germany, 81675
    • Recruiting
    • Department of Internal Medicine II, Technical University of Munich
    • Principal Investigator: Tobias Lahmer, MD, Prof
  • Potsdam, Germany, 14467
    • Recruiting
    • Center for Emergency and Intensive Care Medicine, Hospital Ernst von Bergmann
    • Principal Investigator: Lutz Nibbe
  • Rostock, Germany, 18057
    • Recruiting
    • Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Centre
    • Principal Investigator: Daniel A Reuter, MD, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SoC+CytoSorb treatment; 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; patients will receive CytoSorb therapy in addition to standard of care therapy according to applicable guidelines
No Intervention: Standard of Care (SoC); patients allocated to this group will receive only standard of care therapy according to applicable guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: CytoSorbents Europe GmbH
• Collaborators: BRAHMS GmbH; MedInnovation GmbH
• Investigators: Principal Investigator: Stefan Kluge, Prof, Universitätsklinikum Hamburg-Eppendorf (UKE)

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2022
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: S18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No