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NCT03910062 Clinical Trial

Lower Limb Surveillance During VA-ECLS

Cardiac Arrest Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03910062
Other study ID # PSS2018/MIRECMO-KOSZUTSKI/YB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date June 1, 2020

Study information
Verified date March 2020
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 1, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Lower limb angiography via the reperfusion cannula and NIRS monitoring
Data collection only (lower limb angiography, lower limbs NIRS values).

Locations
Country Name City State
France CHU de Nancy Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Severe limb ischemia Ischemia leading to surgical intervention, functional sequelae, necrosis of the extremities or compartment syndrome 60 days
Secondary Mortality Mortality rate 28 days and 60 days
Secondary Incidence of ischemia of the lower limb during ICU stay StO2 < 50% during 4 consecutive minutes AND/OR StO2 differential > 15% during ICU stay 2 months
Secondary Incidence of renal replacement therapy during ICU stay Number of patients who underwent renal replacement therapy 2 months
Secondary Duration of ICU stay Number of days in the ICU 60 days
Secondary Duration of hospital stay Number of days in the hospital 60 days
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