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

July 31, 2025 updated by: CytoSorbents Europe GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 10117
        • Department of Nephrology and Medical Intensive Care, Charité - University Medical Center
      • Dresden, Germany, 01307
        • Department of Anesthesiology and Critical Care Medicine, University Hospital of Dresden
      • Emden, Germany, 26721
        • Klinikum Emden
      • Erfurt, Germany, 99089
        • Clinic for Interdisciplinary Intensive Care and Intermediate Care, HELIOS Hospital Erfurt
      • Essen, Germany, 45147
        • Department of Nephrology, University Hospital Essen
      • Frankfurt am Main, Germany, 60323
        • Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy, University Hospital Frankfurt
      • Greifswald, Germany, 17475
        • Department of Internal Medicine B, Cardiology, Pneumology, Infectious Diseases, Intensive Care Medicine, University Hospital Greifswald
      • Göttingen, Germany, 37075
        • Department of Anesthesiology, Emergency and Intensive Care Medicine, University of Göttingen
      • Hamburg, Germany, 20251
        • Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf
      • Herford, Germany, 32049
        • Department of Anesthesiology, Surgical Intensive Care, Emergency and Pain Medicine, Ruhr- University Bochum, Klinikum Herford, Herford, Germany
      • Homburg, Germany
        • Department of Anaesthesiology, Intensive Care and Pain Therapy, Saarland University Medical Center and Saarland University Faculty of Medicine
      • Ibbenbüren, Germany, 49477
        • Department of Anesthesiology, Operative Intensive Care Medicine, Pain Management and Emergency Medicine, Hospital Ibbenbüren
      • Leipzig, Germany, 04103
        • Department of Internal Medicine, Neurology and Dermatology, Interdisciplinary Internal Intensive Care Medicine, University Leipzig
      • Munich, Germany, 81675
        • Department of Internal Medicine II, Technical University of Munich
      • Munich, Germany
        • Department of Anaesthesiology and Intensive Care Medicine, Technical University of Munich
      • Potsdam, Germany, 14467
        • Center for Emergency and Intensive Care Medicine, Hospital Ernst von Bergmann
      • Rostock, Germany, 18057
        • Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CytoSorbents Europe GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BRAHMS GmbH
MedInnovation GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan Kluge, Prof, Universitätsklinikum Hamburg-Eppendorf (UKE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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