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

Min-Seok Kim

Status: Enrolling

Conditions: Extracorporeal Membrane Oxygenation Complication

Treatments: Procedure: Distal perfusion catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT05698628

AMC_2022_1691

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Preemptive distal perfusion group

Experimental group

Description:

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

Treatment:

Procedure: Distal perfusion catheterization

Conventional distal perfusion group

Active Comparator group

Description:

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

Treatment:

Procedure: Distal perfusion catheterization