NCT03200314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 13, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2018

Completed
Last Updated

June 26, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

June 26, 2017

Last Update Submit

June 24, 2020

Conditions

ARDSExtracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (1)

  • Recirculation of vvECMO blood flow

    Amount of ECMO blood flow recirculating through the vvECMO circuit

    Once within first week after ICU admission during 4 hours

Secondary Outcomes (2)

  • Reduction of vvECMO blood flow

    Once within first week after ICU admission during 4 hours

  • Arterial blood oxygen content after reduction of vvECMO blood flow

    Once within first week after ICU admission during 4 hours

Interventions

Measurment of blood recirculationOTHER

Ultrasound based measurments of blood recirculating through the vvECMO circuit.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University, Berlin, Germany

Berlin, 13353, Germany

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 27, 2017

Study Start

August 13, 2017

Primary Completion

August 9, 2018

Study Completion

August 9, 2018

Last Updated

June 26, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)