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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preemptive distal perfusion group | Experimental | Distal perfusion catheterization will be done within 1 hour after VA-ECMO application. |
|
| Conventional distal perfusion group | Active Comparator | The conventional group will undergo distal perfusion catheterization at the time of limb ischemia sign. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distal perfusion catheterization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Limb ischemia | Limb ischemia requiring surgical/percutaneous procedure or resulting necrosis or neurologic sequelae in the distal limb during hospitalization | From date of randomization until the date of discharge or assessed up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause of death | From date of randomization until the date of death from any cause, assessed up to 12 months |
| Successful ECMO weaning | Having ECMO removed and not requiring further mechanical support because of recurring cardiogenic shock over the following 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min-Seok Kim, PhD | Contact | 82-2-3010-3948 | msk@amc.seoul.kr | |
| Ah-Ram Kim, MD | Contact | 82-2-3010-0111 | ahram3256@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Min-Seok Kim | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| From date of randomization until the date of discharge or assessed up to 90 days |
| ECMO related complications | Bleeding, systemic thromboembolism, etc. | From date of randomization until the date of ECMO removal, assesed up to 90 days |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |