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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-28

Study Completion Date

2027-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Extracorporeal Membrane Oxygenation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preemptive distal perfusion group

Distal perfusion catheterization will be done within 1 hour after VA-ECMO application.

Group Type EXPERIMENTAL

Distal perfusion catheterization

Intervention Type PROCEDURE

Distal perfusion catheterization will be done within 1 hour after the VA-ECMO application in the preemptive DPC group. The conventional DPC group will undergo distal perfusion catheterization at the time of limb ischemia sign.

Conventional distal perfusion group

The conventional group will undergo distal perfusion catheterization at the time of limb ischemia sign.

Group Type ACTIVE_COMPARATOR

Distal perfusion catheterization

Intervention Type PROCEDURE

Distal perfusion catheterization will be done within 1 hour after the VA-ECMO application in the preemptive DPC group. The conventional DPC group will undergo distal perfusion catheterization at the time of limb ischemia sign.

Interventions

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Distal perfusion catheterization

Distal perfusion catheterization will be done within 1 hour after the VA-ECMO application in the preemptive DPC group. The conventional DPC group will undergo distal perfusion catheterization at the time of limb ischemia sign.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No