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Clinical Trial Details

Trial ID: L0842
Source ID: NCT02722096
Associated Drug: Axillary Block Anesthesia With Ropivacaine And Lidocaine
Title: Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications
Acronym: FAV ss ALR
Status: COMPLETED
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic
Interventions: DRUG: Axillary block anesthesia with Ropivacaine and Lidocaine|DRUG: Local anesthesia with Ropivacaine and Lidocaine
Outcome Measures: Primary: Rate of early complications related to arteriovenous fistula regardless of type, Early complications include stenosis of arteriovenous fistula, thrombosis, lack of maturation, high flow, clinical steal syndrome, arteriovenous fistula infection, arteriovenous fistula hemorrhage, necessity of radiologic ou surgical reintervention,, 6 weeks after surgery | Secondary: Rate of complications related to arteriovenous fistula regardless of type, Complications included stenosis of arteriovenous fistula, thrombosis, lack of maturation, high flow, clinical steal syndrome, arteriovenous fistula infection, arteriovenous fistula hemorrhage, necessity of radiologic ou surgical reintervention., 3 months after surgery|Rate of stenosis of arteriovenous fistula, stenosis of arteriovenous fistula : resistance index \> 0.6, or peak velocity \> 300 cm/s and residual diameter \<3 mm, 6 weeks after surgery|rate of thrombosis, thrombosis: resistance index = 1, 6 weeks after surgery|incidence of abnormal arteriovenous fistula rate, abnormal arteriovenous fistula rate : lack of maturation (blood flow \< 600 ml/min) or high flow (clinical heart failure, blood flow \> 1200 ml/min), 6 weeks after surgery|incidence of clinical steal syndrome, clinical steal syndrome : trophic or neurological disorders, 6 weeks after surgery|incidence of arteriovenous fistula infection, 6 weeks after surgery|incidence of arteriovenous fistula hemorrhage, arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding, 6 weeks after surgery|necessity of radiologic ou surgical reintervention, 6 weeks after surgery|Rate of stenosis of arteriovenous fistula, stenosis of arteriovenous fistula : resistance index \> 0.6, or peak velocity \> 300 cm/s and residual diameter \<3 mm, 3 months after surgery|rate of thrombosis, thrombosis: resistance index = 1, 3 months after surgery|incidence of abnormal arteriovenous fistula rate, abnormal arteriovenous fistula rate : lack of maturation (blood flow \< 600 ml/min) or high flow (clinical heart failure, blood flow \> 1200 ml/min), 3 months after surgery|incidence of clinical steal syndrome, clinical steal syndrome : trophic or neurological disorders, 3 months after surgery|incidence of arteriovenous fistula infection, 3 months after surgery|incidence of arteriovenous fistula hemorrhage, arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding, 3 months after surgery|necessity of radiologic ou surgical reintervention, 3 months after surgery
Sponsor/Collaborators: Sponsor: Hospices Civils de Lyon
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 78
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2014-03
Completion Date: 2018-03-15
Results First Posted:
Last Update Posted: 2018-08-28
Locations: Hopital Edouard Herriot - Service Anesthésie et Réanimation, Lyon, 69437, France
URL: https://clinicaltrials.gov/show/NCT02722096