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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05146336
Other study ID # O06
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 22, 2022
Est. completion date September 2032

Study information

Verified date May 2024
Source CytoSorbents, Inc
Contact Marie-Christin Pawlik, PhD
Phone +49 30 654 99 145
Email cosmos@cytosorbents.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date September 2032
Est. primary completion date June 2032
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Acute Liver Failure
  • Acute Lung Injury
  • Acute on Chronic Liver Failure
  • Acute Respiratory Distress Syndrome
  • Acute-On-Chronic Liver Failure
  • Burns
  • Cardiogenic Shock
  • Communicable Diseases
  • Cytokine Release Syndrome
  • Drug Overdose
  • End Stage Liver Disease
  • Endocarditis
  • Extracorporeal Life Support
  • Hemophagocytic Lymphohistiocytoses
  • Hepatic Insufficiency
  • Infections
  • Infectious Disease
  • Liver Failure
  • Liver Failure, Acute
  • Liver Transplant; Complications
  • Lymphohistiocytosis, Hemophagocytic
  • Pancreatitis
  • Postoperative Vasoplegic Syndrome
  • Respiratory Distress Syndrome
  • Respiratory Distress Syndrome, Newborn
  • Rhabdomyolysis
  • Sepsis
  • Septic Shock
  • Shock
  • Shock, Cardiogenic
  • Syndrome
  • Trauma
  • Vasoplegia

Intervention

Device:
CytoSorb
Sorbent hemoperfusion system

Locations

Country Name City State
Germany Universitätsklinikum Aachen Aachen
Germany Herz- und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen
Germany Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum Bochum
Germany Katholisches Klinikum Bochum, St. Josef-Hospital 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 Klinikum Kassel Kassel
Germany Universitätsklinikum Marburg Marburg
Germany Kliniken Maria Hilf Mönchengladbach
Germany Deutsches Herzzentrum München München
Germany LMU Klinikum München München
Germany Klinikum Oldenburg Oldenburg
Germany Helios Dr. Horst Schmidt Kliniken Wiesbaden Wiesbaden
Italy Ospedale Pediatrico Bambino Gesù Roma
Italy IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo
Portugal ULS São José, Hospital Curry Cabral Lisboa
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Juan Ramón Jimenez Huelva

Sponsors (1)

Lead Sponsor Collaborator
CytoSorbents, Inc

Countries where clinical trial is conducted

Germany,  Italy,  Portugal,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary ICU mortality Through ICU discharge or date of death, whichever comes first [on average 7 days]
Primary In-hospital mortality Through hospital discharge or date of death, whichever comes first [on average 14 days]
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