Lower Limb Surveillance During VA-ECLS

NCT03910062 | Completed

• 1 other identifier: PSS2018/MIRECMO-KOSZUTSKI/YB
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock; Cardiac Arrest; Lower Limb Ischemia

Keywords

VA-ECMO; VA-ECLS; Near-Infrared Spectroscopy (NIRS)

Outcome Measures

Primary Outcomes (1)

• Severe limb ischemia

  Ischemia leading to surgical intervention, functional sequelae, necrosis of the extremities or compartment syndrome

  60 days

Secondary Outcomes (5)

• Mortality

  28 days and 60 days

• Incidence of ischemia of the lower limb during ICU stay

  2 months

• Incidence of renal replacement therapy during ICU stay

  2 months

• Duration of ICU stay

  60 days

• Duration of hospital stay

  60 days

Study Arms (1)

VA ECMO

Patients under VA-ECMO with a femoral reperfusion cannula.

Procedure: Lower limb angiography via the reperfusion cannula and NIRS monitoring

Interventions

Lower limb angiography via the reperfusion cannula and NIRS monitoring PROCEDURE

Data collection only (lower limb angiography, lower limbs NIRS values).

VA ECMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients under Temporary Cardiac Support with VA-ECLS

You may qualify if:

• Temporary circulatory support with VA ECLS
• Age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHU de Nancy

Nancy, France

Location

Related Publications (1)

• 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.

  PMID: 34332620 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Arrest

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Matthieu Koszutski, Dr

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 24, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)