Septic ShockPROCYSSNCT04963920
A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic Shock
A study testing Cytosorb® 300 ml in people with Septic Shock, run by CytoSorbents Europe GmbH at 18 sites in Germany.
Trial summary
To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Cytosorb® 300 ml
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 18 sitesGermany
- Study dates
- 30 Jan 2022to May 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated with standard of care (SOC) according to guidelines for sepsis/septic shock for > 6 and < 30 hours prior to randomization
- 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
- Lactate >2 mmol/l and <8 mmol/l at baseline
- IL-6 ≥ 1000 ng/l at screening
- Minimum 18 years of age
- 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])
Who cannot join
- 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
- Administration of any other vasopressors than NA at time of randomization and within the first 28 hours after randomization
- Indication for va-ECMO at baseline OR a planned va-ECMO within the first 28 hours after randomization
- 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
- Cytokine-specific antibody therapy before inclusion
- Anticipated interruption of CytoSorb® therapy for more than 2 hours within the first 26 hours after start of intervention
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- 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
- Cancer patients currently on chemotherapy with cytostatics, tyrosine kinase inhibitors, or a treatment with antibodies (e.g. PD-1-inhibitors)
- Acute traumatic brain injury
- Decision to limit or withdraw treatment within the study and/or observation period in the ICU
- Pregnancy / breast feeding
- Participation in another interventional study
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Germany18 sites
Department of Nephrology and Medical Intensive Care, Charité - University Medical Center
Berlin, 10117
Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
Berlin, 12203
Department of Anesthesiology and Critical Care Medicine, University Hospital of Dresden
Dresden, 01307
Klinikum Emden
Emden, 26721
Clinic for Interdisciplinary Intensive Care and Intermediate Care, HELIOS Hospital Erfurt
Erfurt, 99089
Department of Nephrology, University Hospital Essen
Essen, 45147
Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy, University Hospital Frankfurt
Frankfurt am Main, 60323
Department of Anesthesiology, Emergency and Intensive Care Medicine, University of Göttingen
Göttingen, 37075
Department of Internal Medicine B, Cardiology, Pneumology, Infectious Diseases, Intensive Care Medicine, University Hospital Greifswald
Greifswald, 17475
Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
Department of Anesthesiology, Surgical Intensive Care, Emergency and Pain Medicine, Ruhr- University Bochum, Klinikum Herford, Herford, Germany
Herford, 32049
Department of Anaesthesiology, Intensive Care and Pain Therapy, Saarland University Medical Center and Saarland University Faculty of Medicine
Homburg
Department of Anesthesiology, Operative Intensive Care Medicine, Pain Management and Emergency Medicine, Hospital Ibbenbüren
Ibbenbueren, 49477
Department of Internal Medicine, Neurology and Dermatology, Interdisciplinary Internal Intensive Care Medicine, University Leipzig
Leipzig, 04103
Department of Internal Medicine II, Technical University of Munich
Munich, 81675
Department of Anaesthesiology and Intensive Care Medicine, Technical University of Munich
Munich
Center for Emergency and Intensive Care Medicine, Hospital Ernst von Bergmann
Potsdam, 14467
Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Centre
Rostock, 18057
About this study
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
To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.
- Conditions
- Septic Shock
- Being tested
- Cytosorb® 300 ml
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytosorb® 300 mlDevice
patients will receive CytoSorb therapy in addition to standard of care therapy according to applicable guidelines
| Study group | Role | What they receive |
|---|---|---|
| SoC+CytoSorb treatment | Experimental | patients allocated to this group, will receive CytoSorb therapy in addition to the standard of care therapy according to applicable guidelines Receives: Device: Cytosorb® 300 ml |
| Standard of Care (SoC) | No intervention | patients allocated to this group will receive only standard of care therapy according to applicable guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in noradrenaline (NA) dose 24 hours after baseline, assessed as mean over the time window 22 to 26 hours after baseline
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start30 Jan 2022
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: Recruitment for the study is currently on hold to allow for a protocol amendment. This revision aims to align the study design with changes in clinical practice since the trial's initiation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CytoSorbents Europe GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BRAHMS GmbH, MedInnovation GmbH
- Responsible party
- Sponsor
- Investigators
- Stefan Kluge, Prof, Principal investigator, Universitätsklinikum Hamburg-Eppendorf (UKE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963920
- Sponsor's protocol ID
- S18
- Acronym
- PROCYSS
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2021
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04963920
- Acronym / sponsor ID
- PROCYSS / S18
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment for the study is currently on hold to allow for a protocol amendment. This revision aims to align the study design with changes in clinical practice since the trial's initiation.
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- CytoSorbents Europe GmbHIndustry (pharma, biotech, devices)
- Collaborators
- BRAHMS GmbH, MedInnovation GmbH
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SoC+CytoSorb treatment | Experimental | Device: Cytosorb® 300 mlpatients allocated to this group, will receive CytoSorb therapy in addition to the standard of care therapy according to applicable guidelines |
| Standard of Care (SoC) | No intervention | –patients allocated to this group will receive only standard of care therapy according to applicable guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients treated with standard of care (SOC) according to guidelines for sepsis/septic shock for > 6 and < 30 hours prior to randomization
- 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
- Lactate >2 mmol/l and <8 mmol/l at baseline
- IL-6 ≥ 1000 ng/l at screening
- Minimum 18 years of age
Key exclusion criteria (12 listed)
- 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
- Administration of any other vasopressors than NA at time of randomization and within the first 28 hours after randomization
- Indication for va-ECMO at baseline OR a planned va-ECMO within the first 28 hours after randomization
- 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
- Cytokine-specific antibody therapy before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytosorb® 300 mlpatients will receive CytoSorb therapy in addition to standard of care therapy according to applicable guidelines | Device | SoC+CytoSorb treatment |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Kluge, Prof principal investigator
Universitätsklinikum Hamburg-Eppendorf (UKE)
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytosorb® 300 ml in people with Septic Shock, run by CytoSorbents Europe GmbH at 18 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.