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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiogenic Shock
• Ischemia
• Lower Limb Ischemia
• Shock, Cardiogenic

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