Blood Recirculation and vvECMO

June 24, 2020 updated by: Steffen Weber-Carstens, Charite University, Berlin, Germany

Measurment of Blood Recirculation and Adjustment of vvECMO Blood Flow During Veno-venous Extracoporeal Membrane Oxygenation

A prospective, observational study will be performed measuring recirculation of blood through a veno-venous Extracoporeal Membrane Oxygenation (vvECMO) in patients with acute respiratory distress syndrome (ARDS) on vvECMO. ECMO blood flow will be adjusted with respect to recirculation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charite University, Berlin, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 years or older requiring veno-venous ECMO for treatment of refractory hypomxemia in ARDS.

Description

Inclusion Criteria:

  • patients aged 18 years or older
  • ARDS
  • veno-venous ECMO

Exclusion Criteria:

  • age < 18 years
  • hemodynamic instability during measurement of recirculation
  • pregnancy
  • inability to obtain patient's consent or consent of legal guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recirculation of vvECMO blood flow
Time Frame: Once within first week after ICU admission during 4 hours
Amount of ECMO blood flow recirculating through the vvECMO circuit
Once within first week after ICU admission during 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of vvECMO blood flow
Time Frame: Once within first week after ICU admission during 4 hours
Reduction of vvECMO blood flow if a significant recirculation can be measured
Once within first week after ICU admission during 4 hours
Arterial blood oxygen content after reduction of vvECMO blood flow
Time Frame: Once within first week after ICU admission during 4 hours
Change in arterial blood oygen content after reduction of vvECMO blood flow
Once within first week after ICU admission during 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Martin Russ, Dr. med., Charite University Hospital Berlin
  • Principal Investigator: Philipp A Pickerodt, Dr. med., Charite University Hospital Berlin
  • Principal Investigator: Steffen Weber-Carstens, PD Dr. med., Charite University Hospital Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 13, 2017

Primary Completion (ACTUAL)

August 9, 2018

Study Completion (ACTUAL)

August 9, 2018

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (ACTUAL)

June 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • EA208317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Extracorporeal Membrane Oxygenation

Clinical Trials on Measurment of blood recirculation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe