Registry for monitoring CytoSorb device use in critically ill patients
CytOSorb TreatMent Of Critically Ill PatientS Registry: International Registry on the Use of CytoSorb in the Critical Care Setting
This study is collecting information on how the CytoSorb device helps critically ill patients to improve care for conditions like septic shock and acute respiratory distress syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Sex | All |
| Sponsor | CytoSorbents, Inc Industry-sponsored |
| Locations | 28 sites (Klagenfurt and 27 other locations) |
| Trial ID | NCT05146336 on ClinicalTrials.gov |
What this trial studies
This registry aims to collect and analyze data on the use of the CytoSorb device in real-world critical care settings. It will provide a comprehensive and scientifically-based resource to measure and improve the quality of patient care for conditions such as septic shock and acute respiratory distress syndrome. The registry will include patients who have given informed consent and are planned to receive the CytoSorb treatment. By documenting outcomes and experiences, the registry seeks to enhance understanding and application of this therapy in critical situations.
Who should consider this trial
Good fit: Ideal candidates include critically ill patients who are planned to receive the CytoSorb device for treatment.
Not a fit: Patients who are using the CytoSorb device solely for antithrombotic removal or during cardiac surgery may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved patient outcomes and care strategies for critically ill patients.
How similar studies have performed: While this registry approach is not novel, it builds on previous successful data collection efforts in critical care settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Planned OR actual CytoSorb® 300 mL device utilization 2. Informed consent for prospective registry participation 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.
Where this trial is running
Klagenfurt and 27 other locations
- Klinikum Klagenfurt am Wörthersee — Klagenfurt, Austria (Recruiting)
- Medizinische Universität Wien — Vienna, Austria (Recruiting)
- Universitätsklinikum Aachen — Aachen, Germany (Recruiting)
- Herz- und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen, Germany (Recruiting)
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum — Bochum, Germany (Recruiting)
- Katholisches Klinikum Bochum, St. Josef-Hospital — Bochum, Germany (Recruiting)
- Universitätsklinikum Essen, Medizinische Intensivtherapie — Essen, Germany (Recruiting)
- Universitätsklinikum Essen, Nephrologie — Essen, Germany (Recruiting)
- Universitätsklinikum Essen, Thorax- und Kardiovaskuläre Chirurgie — Essen, Germany (Recruiting)
- Universitätsmedizin Göttingen, Allgemein-, Viszeral- und Kinderchirurgie — Göttingen, Germany (Recruiting)
- Universitätsmedizin Göttingen, Herzzentrum Göttingen — Göttingen, Germany (Recruiting)
- Klinikum Herford — Herford, Germany (Recruiting)
- Universitätsklinikum Jena — Jena, Germany (Recruiting)
- Klinikum Kassel — Kassel, Germany (Withdrawn)
- Universitätsklinikum Marburg — Marburg, Germany (Recruiting)
- Kliniken Maria Hilf — Mönchengladbach, Germany (Terminated)
- Deutsches Herzzentrum München — München, Germany (Recruiting)
- LMU Klinikum München — München, Germany (Recruiting)
- Klinikum Oldenburg — Oldenburg, Germany (Recruiting)
- Helios Dr. Horst Schmidt Kliniken Wiesbaden — Wiesbaden, Germany (Recruiting)
- Ospedale Pediatrico Bambino Gesù — Roma, Italy (Terminated)
- IRCCS Ospedale Casa Sollievo della Sofferenza — San Giovanni Rotondo, Italy (Recruiting)
- SP ZOZ Szpital Uniwersytecki w Krakowie — Krakow, Poland (Recruiting)
- Uniwersyteckim Spitalem Klinicznym im. Jana Mikulicza - Radeckiego we Wrocławiu — Wroclaw, Poland (Recruiting)
- Unidade Local de Saúde de Coimbra E.P.E — Coimbra, Portugal (Recruiting)
- ULS São José, Hospital Curry Cabral — Lisbon, Portugal (Recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Barcelona, Spain (Recruiting)
- Hospital Juan Ramón Jimenez — Huelva, Spain (Recruiting)
Study contacts
- Principal investigator: Ricard Ferrer Roca, MD — Hospital Vall d'Hebron
- Study coordinator: Robert Wilke
- Email: cosmos@cytosorbents.com
- Phone: +49 30 654 99 145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.