Trial record 1 of 1 for:
PROCYSS
A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic Shock (PROCYSS)
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| ClinicalTrials.gov Identifier: NCT04963920 |
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Recruitment Status :
Recruiting
First Posted : July 15, 2021
Last Update Posted : March 2, 2023
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Sponsor:
CytoSorbents Europe GmbH
Collaborators:
BRAHMS GmbH
MedInnovation GmbH
Information provided by (Responsible Party):
CytoSorbents Europe GmbH
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Brief Summary:
To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Septic Shock | Device: Cytosorb® 300 ml | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 30, 2022 |
| Estimated Primary Completion Date : | August 2023 |
| Estimated Study Completion Date : | November 2023 |
| Arm | Intervention/treatment |
|---|---|
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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
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Device: Cytosorb® 300 ml
patients wiil receive CytoSorb therapy in addition to standard of care therapy according to applicable guidelines |
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No Intervention: SoC
patients allocated to this group will receive only standard of care therapy according to applicable guidelines
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Primary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients treated with standard therapy according to guidelines for sepsis
- Vasoplegic septic shock*, requiring NA ≥ 0.3 µg/kg/min despite adequate fluid resuscitation to maintain MAP ≥ 65 mmHg after at least 6 hours of guideline-oriented initial therapy
- Standard of care (SOC) shock treatment for >6 and < 24 hours
- Serum lactate >2 mmol/l at screening
- IL-6 ≥ 1000 ng/l at screening
- Indication for CRRT according to:
Kidney Disease Improving Global Outcomes (KDIGO) stage 2 AND/ OR Severe refractory metabolic acidosis after fluid resuscitation (HCO3<20 mmol/l and pH <7.20)
- 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 § 21 no. 3 sentence 3 MPG, as applicable
Exclusion Criteria:
- Patients with an abdominal source of infection without a source control intervention within 6h of the determination of the indication OR a planned additional surgical intervention outside of ICU within the first 48 hours
- Patients with abdominal source of infection due to anastomotic leakage
- Septic shock for more than 24 hours prior to inclusion
- Need for use of first-line vasopressors other than NA
- 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 CRRT and / or CytoSorb® 300 mL device therapy for more than 2 hours within the first 48 hours
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963920
Contacts
| Contact: Antje Fechner | +49 30 654 99 145 | clinical@cytosorbents.com | |
| Contact: Marie-Christin Pawlik, PhD | +49 30 654 99 145 | clinical@cytosorbents.com |
Locations
Show 17 study locations
Sponsors and Collaborators
CytoSorbents Europe GmbH
BRAHMS GmbH
MedInnovation GmbH
Investigators
| Principal Investigator: | Stefan Kluge, Prof | Universitätsklinikum Hamburg-Eppendorf (UKE) |
| Responsible Party: | CytoSorbents Europe GmbH |
| ClinicalTrials.gov Identifier: | NCT04963920 |
| Other Study ID Numbers: |
S18 |
| First Posted: | July 15, 2021 Key Record Dates |
| Last Update Posted: | March 2, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Shock, Septic Shock Pathologic Processes Sepsis |
Infections Systemic Inflammatory Response Syndrome Inflammation |