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

Universitätsklinikum Hamburg-Eppendorf24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19

Interventions

CytoSorb-TherapyDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

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.

Time frame: 10 days

Lactate clearance

Improving lactate clearance by lowering serum lactate levels

Time frame: 10 days

Renal replacement therapy

Time with need for renal replacement therapy

Time frame: 10 days

Extracorporeal Membrane Oxygenation

Time with Need for Extracorporeal Membrane Oxygenation

Time frame: 10 days

ICU length of stay

Time frame: 90 days

Time on mechanical ventilation

Data from ClinicalTrials.gov

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