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HaemoAdsorption Nach Reanimation An ECMO

NCT03632837 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-08-16

No results posted yet for this study

Summary

This study evaluates the use of an additional hemoadsorption device in adult patients undergoing veno-arterial extracorporal membrane oxygenation (ECMO) following cardiac arrest and cardiopulmonary resuscitation in respect to its effects on post resuscitation inflammatory syndrome.

At implantation of the ECMO the participants are going to be randomized into a treatment and a control group. The first will be outfitted with a polymer-based adsorption device implemented in the extracorporal circulation established by ECMO for 48h, the control group is going to be treated by ECMO and standard intensive care alone. To detect any significant differences in terms of inflammatory response and patient outcome the investigators will regularly determine the blood levels of certain cytokines in fixed intervalls. In addition, the investigators are going to compare secondary clinical outcome parameters like organ disfunction and 30d mortality.

Conditions

  • Cardiac Arrest
  • Resuscitation
  • Inflammation
  • Multi-Organ Disorder

Interventions

DEVICE

Hemoadsorption

see arm description

Sponsors & Collaborators

  • CytoSorbents Corporation and CytoSorbents Medical Inc.

    collaborator UNKNOWN

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Jens Kubitz, Prof. Dr. · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2019-05-31
Completion
2019-09-30
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03632837 on ClinicalTrials.gov