CytOSorb TreatMent Of Critically Ill PatientS Registry

Recruiting

• Conditions: Cardiogenic Shock; Pancreatitis; Extracorporeal Life Support; Postoperative Endocarditis; Postoperative Vasoplegic Syndrome; Hemophagocytic Lymphohistiocytoses; Trauma; Rhabdomyolysis; Acute on Chronic Liver Failure; Liver Transplant; Complications

• Registration Number: NCT05146336
• Lead Sponsor: CytoSorbents, Inc

Brief Summary

Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-06
• Study Start: 2022-06-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2032-06
• Study Completion: 2032-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Planned OR actual CytoSorb® 300 mL device utilization
2. Informed consent for prospective registry participation

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Exclusion Criteria

1. Use of the CytoSorb® 300 mL device for antithrombotic removal only
2. Intraoperative use of CytoSorb® 300 mL device during cardiac surgery only
3. The occurrence of a complication or other medically justified circumstance that arises after written informed consent has been obtained from the patient and before or during the planned therapy and as a result of which the use of CytoSorb® 300 mL Adsorber is contraindicated or no longer appropriate.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	Through hospital discharge or date of death, whichever comes first [on average 14 days]
ICU mortality	Through ICU discharge or date of death, whichever comes first [on average 7 days]

Trial Locations

Locations (22)

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum; 🇩🇪 Bochum, Germany

Universitätsklinikum Essen, Medizinische Intensivtherapie; 🇩🇪 Essen, Germany

Universitätsklinikum Essen, Nephrologie; 🇩🇪 Essen, Germany

Universitätsklinikum Essen, Thorax- und Kardiovaskuläre Chirurgie; 🇩🇪 Essen, Germany

Universitätsmedizin Göttingen, Herzzentrum Göttingen; 🇩🇪 Göttingen, Germany

Klinikum Herford; 🇩🇪 Herford, Germany

Universitätsklinikum Jena; 🇩🇪 Jena, Germany

Universitätsklinikum Marburg; 🇩🇪 Marburg, Germany

Klinikum Kassel; 🇩🇪 Kassel, Germany

Kliniken Maria Hilf; 🇩🇪 Mönchengladbach, Germany

Klinikum Oldenburg; 🇩🇪 Oldenburg, Germany

LMU Klinikum München; 🇩🇪 München, Germany

IRCCS Ospedale Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Italy

Ospedale Pediatrico Bambino Gesù; 🇮🇹 Roma, Italy

Helios Dr. Horst Schmidt Kliniken Wiesbaden; 🇩🇪 Wiesbaden, Germany

Hospital Juan Ramón Jimenez; 🇪🇸 Huelva, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Herz- und Diabeteszentrum Nordrhein-Westfalen; 🇩🇪 Bad Oeynhausen, Germany

Katholisches Klinikum Bochum, St. Josef-Hospital; 🇩🇪 Bochum, Germany

Deutsches Herzzentrum München; 🇩🇪 München, Germany

ULS São José, Hospital Curry Cabral; 🇵🇹 Lisboa, Portugal