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

NCT04344080 | Completed

• 3 other identifiers: CYTOCOV-19U1111-1250-2078DRKS00021199
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

critically ill; intensive care medicine; CytoSorb; hemoadsorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in organ dysfunction

  10 days

• Lactate clearance

  10 days

• Renal replacement therapy

  10 days

• Extracorporeal Membrane Oxygenation

  10 days

• ICU length of stay

  90 days

Study Arms (2)

CytoSorb-Therapy

ACTIVE COMPARATOR

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

Device: CytoSorb-Therapy

Standard of care

NO INTERVENTION

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

Interventions

CytoSorb-Therapy DEVICE

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

CytoSorb-Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Related Links

• Published trial on PubMed.gov

MeSH Terms

Conditions

COVID-19; Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Kluge, MD

  University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: April 1, 2020
• Primary Completion: April 10, 2021
• Study Completion: April 28, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)