Clinical trial NCT05669183: Hemodynamic Comparison of Peripheral and Central VA ECMO.
Official title: Comparison of Peripheral and Central Intubation on Hemodynamics in Veno-arterial-extracorporeal Membrane Oxygenation (RECOVERY): a National, Multi-center, Prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shock, Cardiogenic
Cardiac Arrest
Extracorporeal Circulation; Complications
Hemodynamics Instability
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Beijing Anzhen Hospital
name: Guangdong Provincial People's Hospital
name: Shaanxi Provincial Center for Disease Control and Prevention
First posted: 2022-12-30
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: Participants require VA ECMO support for cardiogenic shock or cardiac arrest.

Brief summary: The goal of this clinical trial is to monitor hemodynamic differences between central veno-arterial extracorporeal membrane oxygenation (VA ECMO) and peripheral VA ECMO. The main question it aims to answer is:

* Efficacy of the different cannulation strategies for the establishment of for VA-ECMO circulation on hemodynamics and organ perfusion.

Participants require VA ECMO support, will be divided into two groups in an intention-to-treat analysis: central artery cannulation and peripheral artery cannulation.

Researchers will analyze different cannulation strategies for VA-ECMO and identify potential advantages and disadvantages for two groups of VA-ECMO.


Eligibility criteria: Inclusion Criteria:

* Age≥18 years
* Participants with cardiogenic shock
* Obtaining informed consent from participants or their affiliated beneficiaries

Exclusion Criteria:

* Irreversible heart failure
* Contraindications to anticoagulation therapy
* Uncontrolled bleeding
* Irreversible neurological pathology
* Participants limited to extracorporeal cardiopulmonary resuscitation

Primary outcomes:
measure: Oxygen saturation-no. (%)
timeFrame: Through VA ECMO support completion, an average of 1 week
measure: Left ventricular end-diastolic volume (ml)
timeFrame: Through VA ECMO support completion, an average of 1 week
measure: Left ventricular End-systolic volume (ml)
timeFrame: Through VA ECMO support completion, an average of 1 week
measure: Stroke volume (ml)
timeFrame: Through VA ECMO support completion, an average of 1 week
measure: Mitral valve area(cm2)
timeFrame: Through VA ECMO support completion, an average of 1 week
Secondary outcomes:
measure: Rate of successful weaning from VA ECMO
timeFrame: Through study completion, up to 2 years
measure: VA ECMO duration
timeFrame: Through VA ECMO support, an average of 1 week
measure: Cannulation-related complications
timeFrame: Through study completion, up to 2 years
measure: Duration of ICU stay
timeFrame: Through study completion, up to 2 years
measure: Duration of hospital stay
timeFrame: Through study completion, up to 2 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Yang Yan
role: STUDY_DIRECTOR
References: