Reduction of Blood Recirculation in Veno-Venous ECMO

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04754854
• Other study ID #: EA115620
• Status: Recruiting
• Start date: November 20, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2021
• Source: Charite University, Berlin, Germany
• Contact: Steffen Weber-Carstens, Prof. Dr. med.
• Phone: 0049-30450651005
• Email: steffen.weber-carstens[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Extracorporeal Membrane Oxygenation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recirculation fraction	Fraction of blood recirculating through the ECMO circuit	Once within the first week after initiation of ECMO therapy
Secondary	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
Secondary	Extracorporeal Blood Flow	ECMO Blood Flow before vs. after reduction of ECMO blood flow	Once within the first week after initiation of ECMO therapy
Secondary	srporeal Gas flow	ECMO Sweep Gas flow	Once within the first week after initiation of ECMO therapy
Secondary	Length of ECMO therapy	Days on ECMO	Daily until the end of ECMO therapy (approximately 14 days)
Secondary	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
Secondary	Right heart dysfunction	Existing echocardiography will be evaluated for possible right heart dysfunction	Once within the first week after initiation of ECMO therapy
Secondary	Length of mechanical ventilation	Length of mechanical ventilation	Entire duration of the ICU stay (approximately 28 days)
Secondary	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)
Secondary	ICU mortality	ICU mortality	Entire duration of the ICU stay (approximately 28 days)
Secondary	ICU length of stay	ICU length of stay	Entire duration of the ICU stay (approximately 28 days)
Secondary	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)
Secondary	ECMO blood flow over time	ECMO blood and sweep gas flow over time	Daily until the end of ECMO therapy (approximately 14 days)
Secondary	ECMO sweep gas flow over time	ECMO sweep gas flow over time	Daily until the end of ECMO therapy (approximately 14 days)
Secondary	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)
Secondary	Weaning level at ICU discharge	Level of weaning reached at ICU discharge	Discharge from the ICU (approximately 28 days)
Secondary	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)
Secondary	Level of organ dysfunction at ICU discharge	Sepsis-related Organ Failure Assessment Score at ICU discharge	Discharge from the ICU (approximately 28 days)
Secondary	Level of consciousness at ICU discharge	Glasgow Coma Scale at ICU discharge	Discharge from the ICU (approximately 28 days)
Secondary	Level of disease severity	Acute Physiology And Chronic Health Evaluation at ICU discharge	Discharge from the ICU (approximately 28 days)