Distal Perfusion Timing, Early or Conservative, to Prevent Limb Ischemia During Peripheral VA-ECMO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Distal perfusion catheterization.
- Who it may be relevant to
- Registry conditions: Extracorporeal Membrane Oxygenation Complication. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Of Conservative Versus Early Distal Perfusion Strategy to Prevent Acute Limb Ischemia in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients
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).
Interventions
- Procedure 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.
Primary outcome measures
- Limb ischemia [Time frame: From date of randomization until the date of discharge or assessed up to 90 days]
Secondary outcome measures (3)
- All-cause mortality [Time frame: From date of randomization until the date of death from any cause, assessed up to 12 months]
- Successful ECMO weaning [Time frame: From date of randomization until the date of discharge or assessed up to 90 days]
- ECMO related complications [Time frame: From date of randomization until the date of ECMO removal, assesed up to 90 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Asan Medical Center — Seoul
Identifiers
NCT: NCT05698628 · AMC_2022_1691