Comparison Of Conservative Versus Early Distal Perfusion Strategy to Prevent Acute Limb Ischemia in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Extracorporeal Membrane Oxygenation Complication
- Sponsor
- Min-Seok Kim
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Limb ischemia
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Investigators
Min-Seok Kim
Clinical Associate Professor
Asan Medical Center
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)
Outcomes
Primary Outcomes
Limb ischemia
Time Frame: From date of randomization until the date of discharge or assessed up to 90 days
Limb ischemia requiring surgical/percutaneous procedure or resulting necrosis or neurologic sequelae in the distal limb during hospitalization
Secondary Outcomes
- All-cause mortality(From date of randomization until the date of death from any cause, assessed up to 12 months)
- ECMO related complications(From date of randomization until the date of ECMO removal, assesed up to 90 days)
- Successful ECMO weaning(From date of randomization until the date of discharge or assessed up to 90 days)