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

Study Overview
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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).

Official Title
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Comparison Of Conservative Versus Early Distal Perfusion Strategy to Prevent Acute Limb Ischemia in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients

Conditions
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Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment
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* Procedure: Distal perfusion catheterization


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preemptive distal perfusion group<br>Distal perfusion catheterization will be done within 1 hour after VA-ECMO application. | Procedure: Distal perfusion catheterization<br>* 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.<br>|
| Active Comparator: Conventional distal perfusion group<br>The conventional group will undergo distal perfusion catheterization at the time of limb ischemia sign. | Procedure: Distal perfusion catheterization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb ischemia | Limb ischemia requiring surgical/percutaneous procedure or resulting necrosis or neurologic sequelae in the distal limb during hospitalization | From date of randomization until the date of discharge or assessed up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause of death | 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 | From date of randomization until the date of discharge or assessed up to 90 days | 
| ECMO related complications | Bleeding, systemic thromboembolism, etc. | From date of randomization until the date of ECMO removal, assesed up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Membrane Oxygenation, Limb ischemia, Cardiogenic shock