Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04754854

Reduction of Blood Recirculation in Veno-Venous ECMO

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Extracorporeal Membrane Oxygenation Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Successful ECMO blood flow reduction

    Time frame: Once within the first week after initiation of ECMO therapy

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

Secondary outcomes

  1. Recirculation fraction

    Time frame: Once within the first week after initiation of ECMO therapy

    Fraction of blood recirculating through the ECMO circuit

  2. Arterial blood oxygen content

    Time frame: Once within the first week after initiation of ECMO therapy

    Arterial blood oxygen content before vs. after reduction of ECMO blood flow

  3. Extracorporeal blood Flow

    Time frame: Once within the first week after initiation of ECMO therapy

    ECMO Blood Flow before vs. after reduction of ECMO blood flow

  4. Extracorporeal gas flow

    Time frame: Once within the first week after initiation of ECMO therapy

    ECMO Sweep Gas flow

  5. Length of ECMO therapy

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

    Days on ECMO

  6. Cannula position and distance

    Time frame: Once within the first week after initiation of ECMO therapy

    The distance between the tip of drainage and return cannula will be measured in the existing medical imaging (e.g. CT scans)

  7. Right heart dysfunction

    Time frame: Once within the first week after initiation of ECMO therapy

    Existing echocardiography will be evaluated for possible right heart dysfunction

  8. Length of mechanical ventilation

    Time frame: Entire duration of the ICU stay (approximately 28 days)

    Length of mechanical ventilation

  9. Complications of ECMO therapy

    Time frame: Length of ECMO therapy (approximately 14 days)

    Incidence of cannula or system changes (i.e. due to circuit clotting), complications attributed to ECMO therapy like bleeding complications from the cannulation site, transfusion requirements, hemolysis

  10. ICU mortality

    Time frame: Entire duration of the ICU stay (approximately 28 days)

    ICU mortality

  11. ICU length of stay

    Time frame: Entire duration of the ICU stay (approximately 28 days)

    ICU length of stay

  12. Incidence of ICU-acquired organ dysfunctions and complications

    Time frame: Entire duration of the ICU stay (approximately 28 days)

    Cerebral-, cardiovascular-, cardiac- pulmonary-, gastrointestinal- and renal dysfunctions, ICU-acquired infections

  13. ECMO blood flow over time

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

    ECMO blood and sweep gas flow over time

  14. ECMO sweep gas flow over time

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

    ECMO sweep gas flow over time

  15. Mobility at ICU discharge

    Time frame: Discharge from the ICU (approximately 28 days)

    Level of mobility the patient has reached at ICU discharge (recumbent, sitting, standing, walking with help, walking independently)

  16. Weaning level at ICU discharge

    Time frame: Discharge from the ICU (approximately 28 days)

    Level of weaning reached at ICU discharge

  17. Status of mechanical ventilation at ICU discharge

    Time frame: Discharge from the ICU (approximately 28 days)

    Status of mechanical ventilation at ICU discharge including all relevant settings and parameters

  18. Level of organ dysfunction at ICU discharge

    Time frame: Discharge from the ICU (approximately 28 days)

    Sepsis-related Organ Failure Assessment Score at ICU discharge

  19. Level of consciousness at ICU discharge

    Time frame: Discharge from the ICU (approximately 28 days)

    Glasgow Coma Scale at ICU discharge

  20. Level of disease severity

    Time frame: Discharge from the ICU (approximately 28 days)

    Acute Physiology And Chronic Health Evaluation at ICU discharge

  21. Hospital acquired infections related to ECMO therapy

    Time frame: Entire duration of ECMO therapy

    Infection/colonisation of the ECMO circuit

  22. Bleeding and thrombembolic complications of ECMO therapy

    Time frame: Entire duration of ECMO therapy

    Bleeding complications, thrombembolic events, overall use of blood products and coagulation factors, electron microscopic evaluation of selected membranes after change or weaning of the ECMO circuit

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Russ, Dr. med.

CONTACT

[email protected]

0049-30450651268

Steffen Weber-Carstens, Prof. Dr. med.

CONTACT

[email protected]

0049-30450651005

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Reduction of Blood Recirculation in Veno-Venous ECMO Through Ultrasound Dilution Measurements (ECMO Circulation Study)

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2021
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.