Distal Perfusion Timing, Early or Conservative, to Prevent Limb Ischemia During Peripheral VA-ECMO

Not Applicable

Recruiting

• Conditions: Extracorporeal Membrane Oxygenation Complication
• Interventions: Procedure: Distal perfusion catheterization

• Registration Number: NCT05698628
• Lead Sponsor: Min-Seok Kim

Brief Summary

Peripheral VA-ECMO is widely used in refractory cardiogenic shock patients as a salvage therapy. In most cases, the femoral artery and vein are used for the vascular approach. Large cannulas are usually used for proper oxygenation, which may cause peripheral limb ischemia. Distal perfusion catheterization (DPC) at the ipsilateral arterial cannula site is recommended to prevent distal limb ischemia. However, there is no consensus on the proper timing of DPC and additional invasive procedures may cause complications during VA-ECMO support. In this analysis, the investigators compare the clinical outcomes of distal limb ischemia complications between the conventional DPC group (DPC at the time of limb ischemia sign) and the preemptive DPC group (DPC at the time of VA-ECMO application).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-22
• Study First Posted: 2023-01-26
• Study Start: 2023-04-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-15
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age ≥19 years old
• Refractory cardiogenic shock with peripheral VA-ECMO
• Informed consent

Exclusion Criteria

• Unwilling or unable to obtain informed consent from the participant or substitute decision-maker
• Patients who are currently pregnant, postpartum period within 30 days or are breast-feeding
• VA-ECMO application for causes other than cardiogenic shock
• Severe coagulopathy
• Irreversible limb ischemia requiring interventional procedures or surgery at the time of VA-ECMO (previously diagnosed ASO(atherosclerosis obliterans) patients)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional distal perfusion group	Distal perfusion catheterization	The conventional group will undergo distal perfusion catheterization at the time of limb ischemia sign.
Preemptive distal perfusion group	Distal perfusion catheterization	Distal perfusion catheterization will be done within 1 hour after VA-ECMO application.

Primary Outcome Measures

Name	Time	Method
Limb ischemia	From date of randomization until the date of discharge or assessed up to 90 days	Limb ischemia requiring surgical/percutaneous procedure or resulting necrosis or neurologic sequelae in the distal limb during hospitalization

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	From date of randomization until the date of death from any cause, assessed up to 12 months	All-cause of death
ECMO related complications	From date of randomization until the date of ECMO removal, assesed up to 90 days	Bleeding, systemic thromboembolism, etc.
Successful ECMO weaning	From date of randomization until the date of discharge or assessed up to 90 days	Having ECMO removed and not requiring further mechanical support because of recurring cardiogenic shock over the following 30 days

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of