Extracorporeal Membrane Oxygenation Complication
Conditions
Keywords
Extracorporeal Membrane Oxygenation, Limb ischemia, Cardiogenic shock
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).
Interventions
PROCEDUREDistal 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.
Sponsors
Min-Seok Kim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limb ischemia | 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
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | From date of randomization until the date of death from any cause, assessed up to 12 months | All-cause of death |
| Successful ECMO weaning | From date of randomization until the date of discharge or assessed up to 90 days | Having ECMO removed and not requiring further mechanical support because of recurring cardiogenic shock over the following 30 days |
| ECMO related complications | From date of randomization until the date of ECMO removal, assesed up to 90 days | Bleeding, systemic thromboembolism, etc. |
Countries
South Korea
Contacts
Primary ContactMin-Seok Kim, PhD
Backup ContactAh-Ram Kim, MD
Outcome results
None listed