Reduction of Blood Recirculation in Veno-Venous ECMO

NCT04754854 | Recruiting

• 1 other identifier: EA115620
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extracorporeal Membrane Oxygenation; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Successful ECMO blood flow reduction

  Number of patients with a relevant recirculation fraction and successful ECMO blood flow reduction

  Once within the first week after initiation of ECMO therapy

Secondary Outcomes (22)

• Recirculation fraction

  Once within the first week after initiation of ECMO therapy

• Arterial blood oxygen content

  Once within the first week after initiation of ECMO therapy

• Extracorporeal blood Flow

  Once within the first week after initiation of ECMO therapy

• Extracorporeal gas flow

  Once within the first week after initiation of ECMO therapy

• Length of ECMO therapy

  Daily until the end of ECMO therapy (approximately 14 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Martin Russ, Dr. med.

  Charite University Hospital Berlin

  PRINCIPAL INVESTIGATOR

• Philipp A Pickerodt, Dr. med.

  Charite University Hospital Berlin

  PRINCIPAL INVESTIGATOR

• Vladimir Skrypnikov, Dr. med.

  Charite University Hospital Berlin

  PRINCIPAL INVESTIGATOR

• Steffen Weber-Carstens, Prof. Dr. med.

  Charite University Hospital Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steffen Weber-Carstens, Prof. Dr. med.

CONTACT

0049-30450651005; steffen.weber-carstens@charite.de

Martin Russ, Dr. med.

CONTACT

0049-30450651268; martin.russ@charite.de

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: September 14, 2020
• First Posted: February 15, 2021
• Study Start: November 20, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)