CytOSorb TreatMent Of Critically Ill PatientS Registry

Sepsis Clinical Trial

— COSMOS  

Official title:

CytOSorb TreatMent Of Critically Ill PatientS Registry: International Registry on the Use of CytoSorb in the Critical Care Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146336
• Other study ID #: O06
• Status: Recruiting
• Start date: June 22, 2022
• Est. completion date: September 2032

Study information

• Verified date: April 2024
• Source: CytoSorbents, Inc
• Contact: Marie-Christin Pawlik, PhD
• Phone: +49 30 654 99 145
• Email: cosmos[@]cytosorbents.com
• Is FDA regulated: No
• 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.

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	CHULC, 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]