Lower Limb Surveillance During VA-ECLS | NCT03910062

Studies
Lower Limb Surveillance During VA-ECLS

NCT03910062

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

May 24, 2021Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Cardiogenic Shock
Cardiac Arrest
Lower Limb Ischemia

Interventions

Lower limb angiography via the reperfusion cannula and NIRS monitoring

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Apr 1, 2020Actual

Completion Date

Jun 1, 2020Actual

First Submitted Date

Apr 8, 2019

First Submission Date that Met QC Criteria

Apr 9, 2019

First Posted Date

Apr 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2021

Last Update Posted Date

May 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VA ECMO		Patients under VA-ECMO with a femoral reperfusion cannula.	Procedure: Lower limb angiography via the reperfusion cannula and NIRS monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lower limb angiography via the reperfusion cannula and NIRS monitoring	Procedure	Data collection only (lower limb angiography, lower limbs NIRS values).	VA ECMO

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Mortality rate	28 days and 60 days
Incidence of ischemia of the lower limb during ICU stay	StO2 < 50% during 4 consecutive minutes AND/OR StO2 differential > 15% during ICU stay

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients under Temporary Cardiac Support with VA-ECLS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthieu Koszutski, Dr	Central Hospital, Nancy, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nancy		Nancy			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34332620	Derived	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.

ID	Term
D012770	Shock, Cardiogenic
D006323	Heart Arrest

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases