Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Blood Recirculation and vvECMO

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200314
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Steffen Weber-Carstens, Charite University, Berlin, Germany

Brief Summary:
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.

Condition or disease Intervention/treatment
ARDS Extracorporeal Membrane Oxygenation Other: Measurment of blood recirculation

Layout table for study information
Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurment of Blood Recirculation and Adjustment of vvECMO Blood Flow During Veno-venous Extracoporeal Membrane Oxygenation
Actual Study Start Date : August 13, 2017
Actual Primary Completion Date : August 9, 2018
Actual Study Completion Date : August 9, 2018

Intervention Details:
  • Other: Measurment of blood recirculation
    Ultrasound based measurments of blood recirculating through the vvECMO circuit.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 years or older requiring veno-venous ECMO for treatment of refractory hypomxemia in ARDS.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200314


Locations
Layout table for location information
Germany
Charite University, Berlin, Germany
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Steffen Weber-Carstens, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03200314    
Other Study ID Numbers: EA208317
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No