Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19

COVID-19 Clinical Trial

— CYTOCOV-19  

Official title:

Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344080
• Other study ID #: CYTOCOV-19
• Secondary ID: U1111-1250-2078D
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: April 28, 2021

Study information

• Verified date: September 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective randomized single Center study investigates to what extent the physical elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity of severely and critically ill patients with Covid-19.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 28, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• confirmed COVID-19 disease
• refractory shock with need for norepinephrine = 0.2 µg/kg/min for MAP = 65 mmHg
• IL6 = 500 ng/l
• Indication for CRRT or ECMO

Exclusion Criteria:

• Liver cirrhosis Child Pugh C
• "do not resuscitate"-order
• expected survival due to comorbidities < 14 days
• pregnancy or breastfeeding
• participation in another interventional trial

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• CytoSorb-Therapy
Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation)

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours	Percentage of patients with a significant stabilization of hemodynamics ("shock reversal"), defined as a significant reduction of the noradrenaline dose (= 0.05 µg/kg/min) while maintaining mean arterial pressure = 65 mmHg for at least 24 hours compared to control group	24 hours
Secondary	Change in organ dysfunction	Change in organ dysfunction based on "Sequential Organ Failure Assessment" (SOFA) Score The SOFA score is made of 6 variables, each representing an organ system. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure) The worst physiological variables were collected serially every 24 hours of a patient's ICU admission. The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.	10 days
Secondary	Lactate clearance	Improving lactate clearance by lowering serum lactate levels	10 days
Secondary	Renal replacement therapy	Time with need for renal replacement therapy	10 days
Secondary	Extracorporeal Membrane Oxygenation	Time with Need for Extracorporeal Membrane Oxygenation	10 days
Secondary	ICU length of stay	ICU length of stay	90 days
Secondary	Time on mechanical ventilation	Time on mechanical ventilation	10 days
Secondary	Cumulative catecholamine dose	Cumulative catecholamine dose	10 days
Secondary	Overall and ICU mortality	Overall and ICU mortality	90 days
Secondary	Change of plasma Interleukin-6 (IL6) level	Change of plasma Interleukin-6 (IL6) level	10 days
Secondary	Change of plasma Interleukin-10 (IL10) level	Change of plasma Interleukin-10 (IL10) level	10 days
Secondary	Change of plasma Procalcitonin (PCT) level	Change of plasma Procalcitonin (PCT) level	10 days
Secondary	Change of HLA-DR level	Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes	10 days
Secondary	Change of TNF alpha level after ex-vivo stimulation	Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence	10 days

External Links

•   DOI
•   Published trial on PubMed.gov