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Reduction of Blood Recirculation in Veno-Venous ECMO

NCT ID: NCT04754854

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-20

Study Completion Date

2026-10-31

Brief Summary

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Blood which recirculates through the circuit of a veno-venous Extracorporeal Membrane Oxygenation (V-V ECMO) does not contribute to the systemic oxygenation of a patient on V-V ECMO and is called the recirculation fraction (Rf). Theoretically, the optimization of ECMO blood flow is possible using Rf measurements.

A prospective, observational study will be performed measuring the Rf of total ECMO blood flow in patients with acute respiratory distress syndrome (ARDS) on V-V ECMO with an ultrasound dilution technique.

ECMO blood flow will be optimized by reducing ECMO blood flow in accordance with the measured Rf as long as systemic oxygenation is not compromised.

Detailed Description

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Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show that the proportion of patients with a secure ECMO blood flow reduction is greater than 50%. Presumably, 136 Patients have to be included into the trial to study 68 patients with a relevant Rf since not all patients on V-V ECMO suffer from a high Rf.

Conditions

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Extracorporeal Membrane Oxygenation Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Patients aged 18 years or older requiring veno-venous ECMO for treatment of refractory hypoxemia in ARDS.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Steffen Weber-Carstens

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Russ, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University Hospital Berlin

Philipp A Pickerodt, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University Hospital Berlin

Vladimir Skrypnikov, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University Hospital Berlin

Steffen Weber-Carstens, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University Hospital Berlin

Locations

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Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Steffen Weber-Carstens, Prof. Dr. med.

Role: CONTACT

Phone: 0049-30450651005

Email: [email protected]

Martin Russ, Dr. med.

Role: CONTACT

Phone: 0049-30450651268

Email: [email protected]

Facility Contacts

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Steffen Weber-Carstens, Prof. Dr. med.

Role: primary

Martin Russ, Dr. med.

Role: backup

Other Identifiers

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EA115620

Identifier Type: -

Identifier Source: org_study_id