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Completed

NCT Number: NCT03910062

Lower Limb Surveillance During VA-ECLS

Temporary cardiac support by VA-ECLS can lead to lower limb ischemia. The aim of this study is to evaluate a multi-modal strategy (physical examination, NIRS monitoring and angiography through the reperfusion canula) of lower limb surveillance.

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Key information

About this study

VA ECLS is used as a temporary circulatory support during cardiogenic shock and refractory cardiac arrest. Complications of VA ECLS include hemorrhagic, infectious and ischemic events. VA ECLS requires arterial and venous canules which are frequently positioned in the femoral artery and vein, which carries the risk of lower limb ischemia due to retrograde flow and obstruction of the femoral artery lumen. VA ischemia during VA ECLS is frequent (11-52%) and requires the use of reperfusion canula in the femoral common artery on VA ECLS implantation in a primary prevention strategy, before lower limb ischemia occurs. Even with this strategy, lower limb ischemia can occur due to arterial thrombosis, arterial spasm or insufficient blood flow through the reperfusion canula. Lower limb complications are prevented by monitoring of regional oxygen saturation, control of the reperfusion canula position (ultrasound, angiography) and rapid management when lower limb ischemia is suspected. There are no clear recommendations regarding prevention of lower limb complications during VA ECLS and arterial angiography has been described to diagnose ischemic events and evaluate the effectiveness of an intervention such as injection of vasodilators. This study is a prospective evaluation of a strategy to prevent lower limb complications during VA ECLS with a systematic arterial angiography on VA ECLS implantation and when lower limb ischemia is suspected (regional oxygen tissue saturation <50% or a differential >15% between both lower limbs) in addition to continuous NIRS monitoring of lower limbs during VA ECLS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Temporary circulatory support with VA ECLS
  • Age > 18 years

Exclusion criteria

  • Pregnancy
  • History of iodinated contrast allergy
  • History of lower limb amputation above the ankle
  • Lower limb ischemia before starting of VA-ECLS
  • Femoro-axillary VA-ECLS
  • Absence of the lower limb reperfusion canula

Treatment and study plan

Lower limb angiography via the reperfusion cannula and NIRS monitoring

Procedure

Data collection only (lower limb angiography, lower limbs NIRS values).

Primary outcomes

  1. Severe limb ischemia

    Time frame: 60 days

    Ischemia leading to surgical intervention, functional sequelae, necrosis of the extremities or compartment syndrome

Secondary outcomes

  1. Mortality

    Time frame: 28 days and 60 days

    Mortality rate

  2. Incidence of ischemia of the lower limb during ICU stay

    Time frame: 2 months

    StO2 < 50% during 4 consecutive minutes AND/OR StO2 differential > 15% during ICU stay

  3. Incidence of renal replacement therapy during ICU stay

    Time frame: 2 months

    Number of patients who underwent renal replacement therapy

  4. Duration of ICU stay

    Time frame: 60 days

    Number of days in the ICU

  5. Duration of hospital stay

    Time frame: 60 days

    Number of days in the hospital

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Lower Limb Surveillance During VA-ECLS: Evaluation of Angiography Through the Reperfusion Cannula at VA-ECMO Implantation and of Near Infrared Spectroscopy (NIRS) Monitoring

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 10, 2019
Registry last updated
May 24, 2021

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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