Clinical trial NCT05146336: CytOSorb TreatMent Of Critically Ill PatientS Registry
Official title: CytOSorb TreatMent Of Critically Ill PatientS Registry: International Registry on the Use of CytoSorb in the Critical Care Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Septic Shock
Acute Respiratory Distress Syndrome
Trauma
Rhabdomyolysis
Cardiogenic Shock
Pancreatitis
Acute on Chronic Liver Failure
Acute Liver Failure
Burns
Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Cytokine Release Syndrome (CRS)
Extracorporeal Life Support
Postoperative Endocarditis
Hemophagocytic Lymphohistiocytoses
Liver Transplant; Complications
Infectious Disease
Postoperative Vasoplegic Syndrome
Drug Overdose
Sepsis
Lead sponsor: CytoSorbents, Inc
Sponsor class: INDUSTRY
First posted: 2021-12-06
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients receiving CytoSorb therapy

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


Eligibility 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.

Primary outcomes:
measure: ICU mortality
timeFrame: Through ICU discharge or date of death, whichever comes first [on average 7 days]
measure: In-hospital mortality
timeFrame: Through hospital discharge or date of death, whichever comes first [on average 14 days]
Secondary outcomes:
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum, St. Josef-Hospital
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Medizinische Intensivtherapie
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Nephrologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Thorax- und Kardiovaskuläre Chirurgie
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Allgemein-, Viszeral- und Kinderchirurgie
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Herzzentrum Göttingen
city: Herford
country: Germany
facility: Klinikum Herford
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: München
country: Germany
facility: LMU Klinikum München
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
city: Coimbra
country: Portugal
facility: Unidade Local de Saúde de Coimbra E.P.E
city: Lisboa
country: Portugal
facility: ULS São José, Hospital Curry Cabral
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jimenez
Study officials:
affiliation: Hospital Vall d'Hebron
name: Ricard Ferrer Roca, MD
role: PRINCIPAL_INVESTIGATOR
References: