Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization

Chronic Critical Ischemia Clinical Trial

— ELIT  

Official title:

Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01634815
• Other study ID #: 5244
• Status: Terminated
• Phase: N/A
• First received: July 2, 2012
• Last updated: February 19, 2018
• Start date: February 4, 2013
• Est. completion date: August 21, 2015

Study information

• Verified date: February 2018
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 21, 2015
• Est. primary completion date: August 21, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Critical Ischemia
• Ischemia

Intervention

Procedure:
• The Edge
measuring blood lactate

Locations

Country	Name	City	State
France	Clinique de l'Orangerie	Strasbourg
France	Hôpitaux Universitaires de Strasbourg, Service d' Anesthésie Réanimation Chirurgicale	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	48 hours
Secondary	The decrease in the ratio LCO/LCD	The decrease in the ratio LCO / LCD in the immediate aftermath of revascularization	48 hours