Clinical trial NCT03910062: Lower Limb Surveillance During VA-ECLS
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock
Cardiac Arrest
Lower Limb Ischemia
Keywords: VA-ECMO
VA-ECLS
Near-Infrared Spectroscopy (NIRS)
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under Temporary Cardiac Support with VA-ECLS

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.

Eligibility criteria: 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

Primary outcomes:
measure: Severe limb ischemia
timeFrame: 60 days
Secondary outcomes:
measure: Mortality
timeFrame: 28 days and 60 days
measure: Incidence of ischemia of the lower limb during ICU stay
timeFrame: 2 months
measure: Incidence of renal replacement therapy during ICU stay
timeFrame: 2 months
measure: Duration of ICU stay
timeFrame: 60 days
measure: Duration of hospital stay
timeFrame: 60 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Matthieu Koszutski, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koszutski M, Mattei M, Maureira JP, Kimmoun A, Levy B. Assessment of bedside lower limb angiography combined with continuous NIRS monitoring for the detection of lower limb complications of VA-ECMO: an observational monocentric study. Crit Care. 2021 Jul 31;25(1):270. doi: 10.1186/s13054-021-03703-5.