Back to resultsEvaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization (ELIT)
Primary Purpose
Chronic Critical Ischemia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The Edge
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Critical Ischemia
Eligibility Criteria
Inclusion Criteria:
- Ischemia Chronic critical lower limb revascularization procedure requiring fast.
- Written consent informed patient age greater than or equal to 18
Exclusion Criteria:
- Presence of an inflammatory or infectious (erysipelas) in the ischemic member.
Patients at risk for diabetic foot ie, as defined by the HAS (preventing diabetic foot, 2007)
- presence of sensory neuropathy, and / or
- foot deformities (hallux valgus, hammer toes or claw, prominence of the metatarsal heads), and / or
- history of foot ulceration, and / or
- antecedent of one of these factors (ie antécedant diabetic foot).
- Necrosis of the toes.
- Participation in another clinical research protocol.
- Presence of peripheral arterial disease in the bilateral upper limbs.
- Patient in shock whatever the cause.
- Presence of hepatic failure.
- Too impaired general condition (bedridden, dementia, ...)
- Refusal of the patient to participate in the study
- Protected patients
Sites / Locations
- Clinique de l'Orangerie
- Hôpitaux Universitaires de Strasbourg, Service d' Anesthésie Réanimation Chirurgicale
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lactate group
Arm Description
Outcomes
Primary Outcome Measures
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD)
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD) before revascularization of the lower limb in chronic critical limb ischemia (considered positive if> 2).
Secondary Outcome Measures
The decrease in the ratio LCO/LCD
The decrease in the ratio LCO / LCD in the immediate aftermath of revascularization
Full Information
NCT ID
NCT01634815
First Posted
July 2, 2012
Last Updated
February 19, 2018
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT01634815
Brief Title
Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization
Acronym
ELIT
Official Title
Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Enrollment difficulties
Study Start Date
February 4, 2013 (Actual)
Primary Completion Date
August 21, 2015 (Actual)
Study Completion Date
August 21, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast. Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent ischemia in a limb revascularized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Critical Ischemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lactate group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
The Edge
Intervention Description
measuring blood lactate
Primary Outcome Measure Information:
Title
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD)
Description
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD) before revascularization of the lower limb in chronic critical limb ischemia (considered positive if> 2).
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
The decrease in the ratio LCO/LCD
Description
The decrease in the ratio LCO / LCD in the immediate aftermath of revascularization
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemia Chronic critical lower limb revascularization procedure requiring fast.
Written consent informed patient age greater than or equal to 18
Exclusion Criteria:
Presence of an inflammatory or infectious (erysipelas) in the ischemic member.
Patients at risk for diabetic foot ie, as defined by the HAS (preventing diabetic foot, 2007)
presence of sensory neuropathy, and / or
foot deformities (hallux valgus, hammer toes or claw, prominence of the metatarsal heads), and / or
history of foot ulceration, and / or
antecedent of one of these factors (ie antécedant diabetic foot).
Necrosis of the toes.
Participation in another clinical research protocol.
Presence of peripheral arterial disease in the bilateral upper limbs.
Patient in shock whatever the cause.
Presence of hepatic failure.
Too impaired general condition (bedridden, dementia, ...)
Refusal of the patient to participate in the study
Protected patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Diemunsch, MD
Organizational Affiliation
not affiliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de l'Orangerie
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg, Service d' Anesthésie Réanimation Chirurgicale
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization
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