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

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: COVID-19

Treatments: Device: CytoSorb-Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04344080

U1111-1250-2078 (Registry Identifier)

CYTOCOV-19

DRKS00021199 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

CytoSorb-Therapy

Active Comparator group

Description:

Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care in Addition with hemoadsorption using CytoSorb-Adsorber

Treatment:

Device: CytoSorb-Therapy

Standard of care

No Intervention group

Description:

Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care