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

ConditionExtracorporeal Membrane Oxygenation Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorMin-Seok Kim

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥19 years old

Refractory cardiogenic shock with peripheral VA-ECMO

Informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Distal perfusion catheterization

    Procedure/Surgery

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Preemptive distal perfusion groupExperimental treatment 1 intervention
Group B: Conventional distal perfusion groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

ECMO related complications

Bleeding, systemic thromboembolism, etc.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Min-Seok Kim

Lead sponsor

Asan Medical Center

Sponsor institution

Source ClinicalTrials.gov
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