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NCT Number: NCT05698628

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

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).

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Key information

Conditions

Extracorporeal Membrane Oxygenation Complication Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Distal perfusion catheterization

Procedure

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. ECMO related complications

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

    Bleeding, systemic thromboembolism, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Ah-Ram Kim, MD

CONTACT

[email protected]

82-2-3010-0111

Min-Seok Kim, PhD

CONTACT

[email protected]

82-2-3010-3948

Sponsors and collaborators

Lead sponsor

Min-Seok Kim

Other

Registry information

Official study title

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

Acronym: DECIDE-ECMO

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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