Hemodynamic Comparison of Peripheral and Central VA ECMO.

NCT05669183 | Recruiting DMC

• 1 other identifier: XJTU1AF2021CRF-005
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock, Cardiogenic; Cardiac Arrest; Extracorporeal Circulation; Complications; Hemodynamics Instability

Outcome Measures

Primary Outcomes (5)

• Oxygen saturation-no. (%)

  Blood gas analysis

  Through VA ECMO support completion, an average of 1 week

• Left ventricular end-diastolic volume (ml)

  echocardiography

  Through VA ECMO support completion, an average of 1 week

• Left ventricular End-systolic volume (ml)

  echocardiography

  Through VA ECMO support completion, an average of 1 week

• Stroke volume (ml)

  echocardiography

  Through VA ECMO support completion, an average of 1 week

• Mitral valve area(cm2)

  echocardiography

  Through VA ECMO support completion, an average of 1 week

Secondary Outcomes (5)

• Rate of successful weaning from VA ECMO

  Through study completion, up to 2 years

• VA ECMO duration

  Through VA ECMO support, an average of 1 week

• Cannulation-related complications

  Through study completion, up to 2 years

• Duration of ICU stay

  Through study completion, up to 2 years

• Duration of hospital stay

  Through study completion, up to 2 years

Study Arms (2)

Peripheral VA ECMO

Femoral artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO)

Procedure: Veno-arterial extracorporeal membrane oxygenation

Central VA ECMO

Axillary artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO)

Procedure: Veno-arterial extracorporeal membrane oxygenation

Interventions

Veno-arterial extracorporeal membrane oxygenation PROCEDURE

Veno-arterial extracorporeal membrane oxygenation (VA ECMO) is mainly used for circulatory support in patients with severe cardiopulmonary failure. VA ECMO drains the blood from the venous system followed pumping the blood back into the arterial vascular compartment after oxygenation. It can be divided into two cannulation strategies for VA ECMO support, namely peripheral VA ECMO and central VA ECMO based on the arterial cannulation site. Peripheral VA ECMO is established via the femoral artery (FA), whereas axillary artery (AX) is an arterial cannulation site in central VA-ECMO.

Central VA ECMO; Peripheral VA ECMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants require VA ECMO support for cardiogenic shock or cardiac arrest.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Peking University Third Hospital: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Shaanxi Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Arrest

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Yang Yan

  First Affiliated Hospital of Xian Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Yang Yan

CONTACT

0086-18991232621; yangyan3@xjtu.edu.cn

Fengwei Guo

CONTACT

0086-13991259800; guofengwei@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: December 30, 2022
• Study Start: August 12, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)