Distal Perfusion Timing, Early or Conservative, to Prevent Limb Ischemia During Peripheral VA-ECMO

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— DECIDE-ECMO  

Official title:

Comparison Of Conservative Versus Early Distal Perfusion Strategy to Prevent Acute Limb Ischemia in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698628
• Other study ID #: AMC_2022_1691
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2023
• Est. completion date: February 28, 2027

Study information

• Verified date: June 2023
• Source: Asan Medical Center
• Contact: Min-Seok Kim, PhD
• Phone: 82-2-3010-3948
• Email: msk[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication
• Ischemia

Intervention

Procedure:
• Distal 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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Min-Seok Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	All-cause mortality	All-cause of death	From date of randomization until the date of death from any cause, assessed up to 12 months
Secondary	Successful ECMO weaning	Having ECMO removed and not requiring further mechanical support because of recurring cardiogenic shock over the following 30 days	From date of randomization until the date of discharge or assessed up to 90 days
Secondary	ECMO related complications	Bleeding, systemic thromboembolism, etc.	From date of randomization until the date of ECMO removal, assesed up to 90 days