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

NCT ID: NCT04344080

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-04-28

Brief Summary

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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

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

CytoSorb-Therapy

Intervention Type DEVICE

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

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Kluge, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

Related Links

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https://pubmed.ncbi.nlm.nih.gov/36075200/

Published trial on PubMed.gov

Other Identifiers

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U1111-1250-2078

Identifier Type: REGISTRY

Identifier Source: secondary_id

DRKS00021199

Identifier Type: REGISTRY

Identifier Source: secondary_id

CYTOCOV-19

Identifier Type: -

Identifier Source: org_study_id

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