Hemodynamic Comparison of Peripheral and Central VA ECMO.

Recruiting

• Conditions: Cardiac Arrest; Hemodynamics Instability; Extracorporeal Circulation; Complications; Shock, Cardiogenic
• Interventions: Procedure: Veno-arterial extracorporeal membrane oxygenation

• Registration Number: NCT05669183
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-30
• Study First Submitted QC: 2022-12-28
• Study First Posted: 2022-12-30
• Study Start: 2023-08-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Central VA ECMO	Veno-arterial extracorporeal membrane oxygenation	Axillary artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO)
Peripheral VA ECMO	Veno-arterial extracorporeal membrane oxygenation	Femoral artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO)

Primary Outcome Measures

Name	Time	Method
Left ventricular end-diastolic volume (ml)	Through VA ECMO support completion, an average of 1 week	echocardiography
Mitral valve area(cm2)	Through VA ECMO support completion, an average of 1 week	echocardiography
Oxygen saturation-no. (%)	Through VA ECMO support completion, an average of 1 week	Blood gas analysis
Left ventricular End-systolic volume (ml)	Through VA ECMO support completion, an average of 1 week	echocardiography
Stroke volume (ml)	Through VA ECMO support completion, an average of 1 week	echocardiography

Secondary Outcome Measures

Name	Time	Method
Duration of ICU stay	Through study completion, up to 2 years	Intensive care unit length of stay
Duration of hospital stay	Through study completion, up to 2 years	Length of hospital stay
VA ECMO duration	Through VA ECMO support, an average of 1 week	Length of VA ECMO support
Cannulation-related complications	Through study completion, up to 2 years	Cannulation-related complications include bleeding, limb ischemia, revision of cannulation site, wound complications. Limb ischemia is defined as ischemia requiring any surgical procedure, including revision of the arterial/distal perfusion cannula, fasciotomy for compartment syndrome, gangrene, or amputation. Wound complication is defined as infection or requirement of an additional surgical intervention, such as arterial repair, washout with or without vacuum-assisted closure, and muscle flap closure.
Rate of successful weaning from VA ECMO	Through study completion, up to 2 years	Weaning success is defined as survival after complete removal of the extracorporeal circuit without requirement for further mechanical support or heart transplant.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China