NCT05698628

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Apr 2023Feb 2027

First Submitted

Initial submission to the registry

January 12, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 28, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

3.8 years

First QC Date

January 12, 2023

Last Update Submit

June 12, 2023

Conditions

Extracorporeal Membrane Oxygenation Complication

Keywords

Extracorporeal Membrane OxygenationLimb ischemiaCardiogenic shock

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • All-cause mortality

    From date of randomization until the date of death from any cause, assessed up to 12 months

  • Successful ECMO weaning

    From date of randomization until the date of discharge or assessed up to 90 days

  • ECMO related complications

    From date of randomization until the date of ECMO removal, assesed up to 90 days

Study Arms (2)

Preemptive distal perfusion group

EXPERIMENTAL

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

Procedure: Distal perfusion catheterization

Conventional distal perfusion group

ACTIVE COMPARATOR

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

Procedure: Distal perfusion catheterization

Interventions

Distal perfusion catheterizationPROCEDURE

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.

Conventional distal perfusion groupPreemptive distal perfusion group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥19 years old
  • Refractory cardiogenic shock with peripheral VA-ECMO
  • Informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Min-Seok Kim

    Asan Medical Center

    STUDY CHAIR

Central Study Contacts

Min-Seok Kim, PhD

CONTACT

82-2-3010-3948msk@amc.seoul.kr

Ah-Ram Kim, MD

CONTACT

82-2-3010-0111ahram3256@amc.seoul.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 26, 2023

Study Start

April 28, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)