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

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Device: CytoSorb-Therapy

• Registration Number: NCT04344080
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-14
• Primary Completion: 2021-04-10
• Study Completion: 2021-04-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CytoSorb-Therapy	CytoSorb-Therapy	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

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours	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

Secondary Outcome Measures

Name	Time	Method
Time on mechanical ventilation	10 days	Time on mechanical ventilation
Change of plasma Procalcitonin (PCT) level	10 days	Change of plasma Procalcitonin (PCT) level
Change of TNF alpha level after ex-vivo stimulation	10 days	Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence
Lactate clearance	10 days	Improving lactate clearance by lowering serum lactate levels
Extracorporeal Membrane Oxygenation	10 days	Time with Need for Extracorporeal Membrane Oxygenation
Cumulative catecholamine dose	10 days	Cumulative catecholamine dose
Overall and ICU mortality	90 days	Overall and ICU mortality
Change in organ dysfunction	10 days	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.
Renal replacement therapy	10 days	Time with need for renal replacement therapy
ICU length of stay	90 days	ICU length of stay
Change of plasma Interleukin-6 (IL6) level	10 days	Change of plasma Interleukin-6 (IL6) level
Change of plasma Interleukin-10 (IL10) level	10 days	Change of plasma Interleukin-10 (IL10) level
Change of HLA-DR level	10 days	Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany