Neuromuscular Electrostimulation in Radiocephalic Fistula — NMS  

Arteriovenous Fistula Clinical Trial

Official title: Neuromuscular Electrostimulation Effect on the Maturation of Native Vascular Access (VA) Patients With Kidney Disease 5- Chronic Stages 5d Estimated by Doppler Ultrasound

Status Recruiting

Clinical Trial Summary

• Objective: To analyze the effect of neuromuscular electrostimulation in the maturation of radiocephalic arteriovenous fistula (RC-AVF) patients with chronic kidney disease (CKD) stage 5-5D

• Design: Clinical Trial with medical devices, 18-month, single-center, within the hospital setting.

• Disease or disorder study: vascular Access maturation.

• Population: Patients with CKD stage 5-5D at the research center.

• Project duration: 78 weeks

• Methodology:

• Patients with CKD stages 5-5D that has undergone a native AV in service stations to give their informed consent and meeting the inclusion criteria will be included.

• At baseline two study groups were established:

• Group 1: neuromuscular electrostimulation

• Group 2: isometric exercises

Clinical Trial Description

• Objective: To analyze the effect of neuromuscular electrostimulation in the maturation of radiocephalic arteriovenous fistula (RC-AVF) patients with chronic kidney disease (CKD) stage 5-5D

• Design: Clinical Trial with medical devices, 18-month, single-center, within the hospital setting.

• Disease or disorder study: vascular Access maturation.

• Population: Patients with CKD stage 5-5D at the research center.

• Project duration: 78 weeks

• Methodology:

• Patients with CKD stages 5-5D that has undergone a native AV in service stations to give their informed consent and meeting the inclusion criteria will be included.

• At baseline two study groups were established:

• Group 1: neuromuscular electrostimulation

• Group 2: isometric exercises

• At baseline, patients included in the study the main demographic variables were collected, anthropometric, biochemical parameters, hemodynamic data, Eco Doppler of AV (ECO mapping) and prescribed medical treatment.

• Likewise, they will be made an assessment of their muscle strength by skinfold and upper limb static dynamometry in which was made the native AV.

• During the study period the following phases were established:

• Phase 1 (4 weeks):

• The control group will receive the usual care on an outpatient AV.

• Patients assigned to group, will perform a program of AV electrostimulation in the affected upper extremity (according to program) after 7 days of completion of native AV.

• At the end of this phase both groups were conducted an ECO doppler (ECO4s) AV regulated by Vascular Surgery.

• Phase 2 (8 weeks):

• The control group will receive the usual care on an outpatient AV.

• Patients assigned to group, will perform a program of AV electrostimulation in the affected upper extremity (according to program)

• At the end of this phase, both groups were conducted an ECO doppler (ECO8s) is regulated by the AV Vascular Surgery

• During all phases of the study, patients on hemodialysis follow their analytical controls programmed by Nephrology and receive medical treatment according to standard clinical practice.

• At the end of each phase of the study, all patients were performed an assessment of their muscle strength by centimetría, skinfold thickness and static dynamometry member in which AV has been made.

• Calendar: A provisional timetable is presented

• Presentation of the CEIC study: September 2014

• inclusion Period: 78 weeks

• Follow-up period: 2 months

• Close database: 1 month

• Statistical analysis: 1 month

• Source of funding: Not available ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

• NCT number: NCT02925845
• Study type: Interventional
• Source: Hospital de Terrassa
• Contact: Lucía Inés Martínez Carnovale, MD
• Phone: +340615950992
• Email: luciaimartinez@hotmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Completion date: January 2017