Actively Recruiting
Comparison of Conservative Versus Early Distal Perfusion Strategy to Prevent Acute Limb Ischemia in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients
Led by Min-Seok Kim · Updated on 2023-06-15
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the timing of distal perfusion catheterization (DPC) to prevent limb ischemia in patients receiving peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO) for refractory cardiogenic shock. Large cannulas used in the femoral artery and vein during VA-ECMO can cause peripheral limb ischemia. This study compares outcomes between an early DPC approach done within 1 hour after VA-ECMO application and a conventional approach where DPC is performed only when signs of limb ischemia appear. Participants are randomly assigned to one of two groups: the preemptive DPC group receives catheterization within an hour of VA-ECMO start, while the conventional group receives catheterization only after limb ischemia signs develop. The study assesses the effect of these timing strategies on limb ischemia and other complications during ECMO support. During the study, researchers monitor participants for limb ischemia from randomization until discharge or up to 90 days. They also track all-cause mortality for up to 12 months, successful ECMO weaning, and ECMO-related complications. The trial involves ongoing clinical assessments to evaluate safety and effectiveness of the two catheterization timing approaches in patients undergoing VA-ECMO for cardiogenic shock.
CONDITIONS
Brief Title
Distal Perfusion Timing, Early or Conservative, to Prevent Limb Ischemia During Peripheral VA-ECMO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Diagnosis of refractory cardiogenic shock requiring peripheral VA-ECMO
- Ability to provide informed consent
You will not qualify if you...
- Unwilling or unable to provide informed consent
- Currently pregnant, within 30 days postpartum, or breastfeeding
- VA-ECMO applied for reasons other than cardiogenic shock
- Severe coagulopathy
- Irreversible limb ischemia needing intervention or surgery at VA-ECMO start (e.g., diagnosed atherosclerosis obliterans)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days or until discharge
Participants receive peripheral VA-ECMO and are assigned to either early distal perfusion catheterization within 1 hour after VA-ECMO application or conventional catheterization at the time of limb ischemia signs.
Visits occur as needed during ECMO support
Duration - Up to 12 months
Participants are monitored for all-cause mortality and complications up to 12 months after randomization.
Periodic follow-up visits up to 12 months
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
M
Min-Seok Kim, PhD
A
Ah-Ram Kim, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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