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

June 12, 2023 updated by: Min-Seok Kim

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limb ischemia
Time Frame: 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
From date of randomization until the date of discharge or assessed up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: From date of randomization until the date of death from any cause, assessed up to 12 months
All-cause of death
From date of randomization until the date of death from any cause, assessed up to 12 months
Successful ECMO weaning
Time Frame: 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
From date of randomization until the date of discharge or assessed up to 90 days
ECMO related complications
Time Frame: From date of randomization until the date of ECMO removal, assesed up to 90 days
Bleeding, systemic thromboembolism, etc.
From date of randomization until the date of ECMO removal, assesed up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Min-Seok Kim

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 22, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC_2022_1691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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