Extracorporeal Membrane Oxygenation ComplicationDECIDE-ECMONCT05698628
Distal Perfusion Timing, Early or Conservative, to Prevent Limb Ischemia During Peripheral VA-ECMO
A study testing Distal perfusion catheterization in people with Extracorporeal Membrane Oxygenation Complication, run by Min-Seok Kim at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Distal perfusion catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Apr 2023to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥19 years old
- Refractory cardiogenic shock with peripheral VA-ECMO
- Informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Min-Seok Kim, PhD, 82-2-3010-3948, msk@amc.seoul.kr
Ah-Ram Kim, MD, 82-2-3010-0169, ahram3256@amc.seoul.kr
About this study
Official title: 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).
- Being tested
- Distal perfusion catheterization
- Keywords
- Extracorporeal Membrane Oxygenation, Limb ischemia, Cardiogenic shock
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal perfusion catheterizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Preemptive distal perfusion group | Experimental | Distal perfusion catheterization will be done within 1 hour after VA-ECMO application. Receives: 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. Receives: Procedure: Distal perfusion catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb ischemia
Limb ischemia requiring surgical/percutaneous procedure or resulting necrosis or neurologic sequelae in the distal limb during hospitalization
Measured: From date of randomization until the date of discharge or assessed up to 90 days
Secondary outcomes (3)
All-cause mortality
All-cause of death
Measured: From date of randomization until the date of death from any cause, assessed up to 12 months
Successful ECMO weaning
Having ECMO removed and not requiring further mechanical support because of recurring cardiogenic shock over the following 30 days
Measured: From date of randomization until the date of discharge or assessed up to 90 days
ECMO related complications
Bleeding, systemic thromboembolism, etc.
Measured: From date of randomization until the date of ECMO removal, assesed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start28 Apr 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Seok Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min-Seok Kim, Asan Medical Center
- Investigators
- Min-Seok Kim, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698628
- Sponsor's protocol ID
- AMC_2022_1691
- Acronym
- DECIDE-ECMO
- Status last verified
- Jun 2023
- First submitted
- 12 Jan 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Conservative Versus Early Distal Perfusion Strategy to Prevent Acute Limb Ischemia in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients
- ClinicalTrials.gov ID
- NCT05698628
- Acronym / sponsor ID
- DECIDE-ECMO / AMC_2022_1691
- Keywords
- Extracorporeal Membrane Oxygenation, Limb ischemia, Cardiogenic shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Min-Seok KimUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preemptive distal perfusion group | Experimental | Procedure: Distal perfusion catheterizationDistal perfusion catheterization will be done within 1 hour after VA-ECMO application. |
| Conventional distal perfusion group | Active comparator | Procedure: Distal perfusion catheterizationThe conventional group will undergo distal perfusion catheterization at the time of limb ischemia sign. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥19 years old
- Refractory cardiogenic shock with peripheral VA-ECMO
- Informed consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal perfusion catheterizationDistal 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. | Procedure or surgery | Conventional distal perfusion group, Preemptive distal perfusion group |
Primary outcome
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
3 secondary outcomes
All-cause mortality
Time frame: 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
ECMO related complications
Time frame: From date of randomization until the date of ECMO removal, assesed up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min-Seok Kim study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal perfusion catheterization in people with Extracorporeal Membrane Oxygenation Complication, run by Min-Seok Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min-Seok Kim, PhD (82-2-3010-3948, msk@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb ischemia (time frame: From date of randomization until the date of discharge or assessed up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.