Timing of Distal Perfusion to Prevent Limb Ischemia in ECMO Patients
Comparison Of Conservative Versus Early Distal Perfusion Strategy to Prevent Acute Limb Ischemia in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients
This study tests whether giving a special treatment to improve blood flow in the legs right when symptoms start is better than doing it right at the beginning of heart support for patients with severe heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05698628 on ClinicalTrials.gov |
What this trial studies
This study investigates the timing of distal perfusion catheterization (DPC) in patients undergoing peripheral VA-ECMO for refractory cardiogenic shock. It compares outcomes between patients receiving DPC at the onset of limb ischemia symptoms versus those receiving it preemptively at the start of VA-ECMO. The goal is to determine which approach better prevents complications related to limb ischemia during ECMO support. The study aims to provide insights into optimizing care for patients experiencing severe cardiac issues.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older experiencing refractory cardiogenic shock requiring peripheral VA-ECMO.
Not a fit: Patients with irreversible limb ischemia or those requiring immediate surgical intervention will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of limb ischemia in patients undergoing VA-ECMO, improving their overall outcomes.
How similar studies have performed: While the approach of DPC is established, the specific timing comparison in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Min-Seok Kim, PhD
- Email: msk@amc.seoul.kr
- Phone: 82-2-3010-3948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.