Clinical trial NCT04754854: Reduction of Blood Recirculation in Veno-Venous ECMO
Official title: Reduction of Blood Recirculation in Veno-Venous ECMO Through Ultrasound Dilution Measurements (ECMO Circulation Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extracorporeal Membrane Oxygenation
Acute Respiratory Distress Syndrome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

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

Primary outcomes:
measure: Successful ECMO blood flow reduction
timeFrame: Once within the first week after initiation of ECMO therapy
Secondary outcomes:
measure: Recirculation fraction
timeFrame: Once within the first week after initiation of ECMO therapy
measure: Arterial blood oxygen content
timeFrame: Once within the first week after initiation of ECMO therapy
measure: Extracorporeal blood Flow
timeFrame: Once within the first week after initiation of ECMO therapy
measure: Extracorporeal gas flow
timeFrame: Once within the first week after initiation of ECMO therapy
measure: Length of ECMO therapy
timeFrame: Daily until the end of ECMO therapy (approximately 14 days)
measure: Cannula position and distance
timeFrame: Once within the first week after initiation of ECMO therapy
measure: Right heart dysfunction
timeFrame: Once within the first week after initiation of ECMO therapy
measure: Length of mechanical ventilation
timeFrame: Entire duration of the ICU stay (approximately 28 days)
measure: Complications of ECMO therapy
timeFrame: Length of ECMO therapy (approximately 14 days)
measure: ICU mortality
timeFrame: Entire duration of the ICU stay (approximately 28 days)
measure: ICU length of stay
timeFrame: Entire duration of the ICU stay (approximately 28 days)
measure: Incidence of ICU-acquired organ dysfunctions and complications
timeFrame: Entire duration of the ICU stay (approximately 28 days)
measure: ECMO blood flow over time
timeFrame: Daily until the end of ECMO therapy (approximately 14 days)
measure: ECMO sweep gas flow over time
timeFrame: Daily until the end of ECMO therapy (approximately 14 days)
measure: Mobility at ICU discharge
timeFrame: Discharge from the ICU (approximately 28 days)
measure: Weaning level at ICU discharge
timeFrame: Discharge from the ICU (approximately 28 days)
measure: Status of mechanical ventilation at ICU discharge
timeFrame: Discharge from the ICU (approximately 28 days)
measure: Level of organ dysfunction at ICU discharge
timeFrame: Discharge from the ICU (approximately 28 days)
measure: Level of consciousness at ICU discharge
timeFrame: Discharge from the ICU (approximately 28 days)
measure: Level of disease severity
timeFrame: Discharge from the ICU (approximately 28 days)
measure: Hospital acquired infections related to ECMO therapy
timeFrame: Entire duration of ECMO therapy
measure: Bleeding and thrombembolic complications of ECMO therapy
timeFrame: Entire duration of ECMO therapy
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Study officials:
affiliation: Charite University Hospital Berlin
name: Martin Russ, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University Hospital Berlin
name: Philipp A Pickerodt, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University Hospital Berlin
name: Vladimir Skrypnikov, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University Hospital Berlin
name: Steffen Weber-Carstens, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: