search
Back to results

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

Primary Purpose

Extracorporeal Membrane Oxygenation Complication

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Distal perfusion catheterization
Sponsored by
Min-Seok Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extracorporeal Membrane Oxygenation Complication focused on measuring Extracorporeal Membrane Oxygenation, Limb ischemia, Cardiogenic shock

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preemptive distal perfusion group

Conventional distal perfusion group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Limb ischemia
Limb ischemia requiring surgical/percutaneous procedure or resulting necrosis or neurologic sequelae in the distal limb during hospitalization

Secondary Outcome Measures

All-cause mortality
All-cause of death
Successful ECMO weaning
Having ECMO removed and not requiring further mechanical support because of recurring cardiogenic shock over the following 30 days
ECMO related complications
Bleeding, systemic thromboembolism, etc.

Full Information

First Posted
January 12, 2023
Last Updated
June 12, 2023
Sponsor
Min-Seok Kim
search

1. Study Identification

Unique Protocol Identification Number
NCT05698628
Brief Title
Distal Perfusion Timing, Early or Conservative, to Prevent Limb Ischemia During Peripheral VA-ECMO
Acronym
DECIDE-ECMO
Official Title
Comparison Of Conservative Versus Early Distal Perfusion Strategy to Prevent Acute Limb Ischemia in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
February 28, 2027 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min-Seok Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extracorporeal Membrane Oxygenation Complication
Keywords
Extracorporeal Membrane Oxygenation, Limb ischemia, Cardiogenic shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preemptive distal perfusion group
Arm Type
Experimental
Arm Description
Distal perfusion catheterization will be done within 1 hour after VA-ECMO application.
Arm Title
Conventional distal perfusion group
Arm Type
Active Comparator
Arm Description
The conventional group will undergo distal perfusion catheterization at the time of limb ischemia sign.
Intervention Type
Procedure
Intervention Name(s)
Distal perfusion catheterization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Limb ischemia
Description
Limb ischemia requiring surgical/percutaneous procedure or resulting necrosis or neurologic sequelae in the distal limb during hospitalization
Time Frame
From date of randomization until the date of discharge or assessed up to 90 days
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
All-cause of death
Time Frame
From date of randomization until the date of death from any cause, assessed up to 12 months
Title
Successful ECMO weaning
Description
Having ECMO removed and not requiring further mechanical support because of recurring cardiogenic shock over the following 30 days
Time Frame
From date of randomization until the date of discharge or assessed up to 90 days
Title
ECMO related complications
Description
Bleeding, systemic thromboembolism, etc.
Time Frame
From date of randomization until the date of ECMO removal, assesed up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min-Seok Kim, PhD
Phone
82-2-3010-3948
Email
msk@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ah-Ram Kim, MD
Phone
82-2-3010-0111
Email
ahram3256@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Seok Kim
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min-Seok Kim, PhD
Phone
82-2-3010-3948
Email
msk@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Ah-Ram Kim, MD
Phone
82-2-3010-0169
Email
ahram3256@amc.seoul.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs