Comparison of Preemptive Versus Conventional Distal Perfusion in Peripheral VA-ECMO

Sponsor
Min-Seok Kim (Other)
Overall Status
Recruiting
CT.gov ID
NCT05698628
Collaborator
(none)
400
1
2
48
8.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Distal perfusion catheterization
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison Of Conventional Versus Preemptive Distal Perfusion Strategy in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients to Prevent Acute Limb Ischemia
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Feb 28, 2027
Anticipated Study Completion Date :
Feb 28, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Preemptive distal perfusion group

Distal perfusion catheterization will be done within 1 hour after VA-ECMO application.

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.

Active Comparator: Conventional distal perfusion group

The conventional group will undergo distal perfusion catheterization at the time of limb ischemia sign.

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. All-cause mortality [From date of randomization until the date of death from any cause, assessed up to 12 months]

    All-cause of death

  2. 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

  3. ECMO related complications [From date of randomization until the date of ECMO removal, assesed up to 90 days]

    Bleeding, systemic thromboembolism, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center Seoul Korea, Republic of 05505

Sponsors and Collaborators

  • Min-Seok Kim

Investigators

  • Study Chair: Min-Seok Kim, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Min-Seok Kim, Clinical Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT05698628
Other Study ID Numbers:
  • AMC_2022_1691
First Posted:
Jan 26, 2023
Last Update Posted:
Feb 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Min-Seok Kim, Clinical Associate Professor, Asan Medical Center

Study Results

No Results Posted as of Feb 2, 2023