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

Min-Seok Kim400 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Extracorporeal Membrane Oxygenation Complication

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Limb ischemia

Limb ischemia requiring surgical/percutaneous procedure or resulting necrosis or neurologic sequelae in the distal limb during hospitalization

Time frame: From date of randomization until the date of discharge or assessed up to 90 days

Secondary Outcomes

All-cause mortality

All-cause of death

Time frame: From date of randomization until the date of death from any cause, assessed up to 12 months

Successful ECMO weaning

Having ECMO removed and not requiring further mechanical support because of recurring cardiogenic shock over the following 30 days

Time frame: From date of randomization until the date of discharge or assessed up to 90 days

ECMO related complications

Bleeding, systemic thromboembolism, etc.

Time frame: From date of randomization until the date of ECMO removal, assesed up to 90 days

Central Contacts

Min-Seok Kim, PhD

CONTACT

82-2-3010-3948 msk@amc.seoul.kr

Ah-Ram Kim, MD