Reduction of Blood Recirculation in Veno-Venous ECMO

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

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.

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation; Acute Respiratory Distress Syndrome

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 136

Contacts and Locations

• Study Contact: Name: Steffen Weber-Carstens, Prof. Dr. med.; Phone Number: 0049-30450651005; Email: steffen.weber-carstens@charite.de
• Study Contact Backup: Name: Martin Russ, Dr. med.; Phone Number: 0049-30450651268; Email: martin.russ@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
    • Contact: Martin Russ, Dr. med.; Phone Number: 0049-30450651268; Email: martin.russ@charite.de
    • Contact: Steffen Weber-Carstens, Prof. Dr. med.; Phone Number: 0049-30450651055; Email: steffen.webercarstens@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recirculation fraction	Fraction of blood recirculating through the ECMO circuit	Once within the first week after initiation of ECMO therapy
Arterial blood oxygen content	Arterial blood oxygen content before vs. after reduction of ECMO blood flow	Once within the first week after initiation of ECMO therapy
Length of ECMO therapy	Days on ECMO	Daily until the end of ECMO therapy (approximately 14 days)
Cannula position and distance	The distance between the tip of drainage and return cannula will be measured in the existing medical imaging (e.g. CT scans)	Once within the first week after initiation of ECMO therapy
Right heart dysfunction	Existing echocardiography will be evaluated for possible right heart dysfunction	Once within the first week after initiation of ECMO therapy
Length of mechanical ventilation	Length of mechanical ventilation	Entire duration of the ICU stay (approximately 28 days)
Complications of ECMO therapy	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	Length of ECMO therapy (approximately 14 days)
ICU mortality	ICU mortality	Entire duration of the ICU stay (approximately 28 days)
ICU length of stay	ICU length of stay	Entire duration of the ICU stay (approximately 28 days)
Incidence of ICU-acquired organ dysfunctions and complications	Cerebral-, cardiovascular-, cardiac- pulmonary-, gastrointestinal- and renal dysfunctions, ICU-acquired infections	Entire duration of the ICU stay (approximately 28 days)
ECMO blood flow over time	ECMO blood and sweep gas flow over time	Daily until the end of ECMO therapy (approximately 14 days)
ECMO sweep gas flow over time	ECMO sweep gas flow over time	Daily until the end of ECMO therapy (approximately 14 days)
Mobility at ICU discharge	Level of mobility the patient has reached at ICU discharge (recumbent, sitting, standing, walking with help, walking independently)	Discharge from the ICU (approximately 28 days)
Weaning level at ICU discharge	Level of weaning reached at ICU discharge	Discharge from the ICU (approximately 28 days)
Status of mechanical ventilation at ICU discharge	Status of mechanical ventilation at ICU discharge including all relevant settings and parameters	Discharge from the ICU (approximately 28 days)
Level of organ dysfunction at ICU discharge	Sepsis-related Organ Failure Assessment Score at ICU discharge	Discharge from the ICU (approximately 28 days)
Level of consciousness at ICU discharge	Glasgow Coma Scale at ICU discharge	Discharge from the ICU (approximately 28 days)
Level of disease severity	Acute Physiology And Chronic Health Evaluation at ICU discharge	Discharge from the ICU (approximately 28 days)
Extracorporeal blood Flow	ECMO Blood Flow before vs. after reduction of ECMO blood flow	Once within the first week after initiation of ECMO therapy
Extracorporeal gas flow	ECMO Sweep Gas flow	Once within the first week after initiation of ECMO therapy
Hospital acquired infections related to ECMO therapy	Infection/colonisation of the ECMO circuit	Entire duration of ECMO therapy
Bleeding and thrombembolic complications 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	Entire duration of ECMO therapy

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Martin Russ, Dr. med., Charité University Hospital Berlin; Principal Investigator: Philipp A Pickerodt, Dr. med., Charité University Hospital Berlin; Principal Investigator: Vladimir Skrypnikov, Dr. med., Charité University Hospital Berlin; Principal Investigator: Steffen Weber-Carstens, Prof. Dr. med., Charité University Hospital Berlin

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: EA115620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No