Lower Limb Surveillance During VA-ECLS

Completed

• Conditions: Cardiac Arrest; Lower Limb Ischemia; Cardiogenic Shock
• Interventions: Procedure: Lower limb angiography via the reperfusion cannula and NIRS monitoring

• Registration Number: NCT03910062
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-10
• Status Verified: 2020-03
• Primary Completion: 2020-04-01
• Study Completion: 2020-06-01
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VA ECMO	Lower limb angiography via the reperfusion cannula and NIRS monitoring	Patients under VA-ECMO with a femoral reperfusion cannula.

Primary Outcome Measures

Name	Time	Method
Severe limb ischemia	60 days	Ischemia leading to surgical intervention, functional sequelae, necrosis of the extremities or compartment syndrome

Secondary Outcome Measures

Name	Time	Method
Mortality	28 days and 60 days	Mortality rate
Incidence of ischemia of the lower limb during ICU stay	2 months	StO2 \< 50% during 4 consecutive minutes AND/OR StO2 differential \> 15% during ICU stay
Incidence of renal replacement therapy during ICU stay	2 months	Number of patients who underwent renal replacement therapy
Duration of ICU stay	60 days	Number of days in the ICU
Duration of hospital stay	60 days	Number of days in the hospital

Trial Locations

Locations (1)

CHU de Nancy; 🇫🇷 Nancy, France