Neuromuscular Electrostimulation in Radiocephalic Fistula

Arteriovenous Fistula Clinical Trial

— NMS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02925845
• Other study ID #: VES-COMPAVI-2014-01
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2016
• Last updated: October 4, 2016
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Hospital de Terrassa
• Contact: Lucía Inés Martínez Carnovale, MD
• Phone: +340615950992
• Email: luciaimartinez[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• Inclusion criteria:

• Patients aged less than 18 years old

• Patients with tracking CCEE Nephrology than 3 months

• Patients with AV native AV upper limb without prior

• Patients give their written informed consent

• Exclusion criteria:

• prior cardiovascular event (acute myocardial infarction, unstable angina, stroke ....) in the last 3 months.

• AV prior to HD in same upper extremity

• Not have given informed written consent

• Carrier cardiac pacemaker

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

Intervention

Device:
• Neuromuscular electrostimulation
The device CompexTheta 400i provided with various developmental programs rehabilitation exercise with different phases, types and current is used. an adaptive program (heating, toning, muscular atrophy, strength-endurance) will be established for each patient during the study period. It shall apply at the level of the muscle bellies of the flexor and extensor muscles of the forearm dela upper extremity AV created. Electrodes are positioned at the anatomical reference positions. The intensity of the current will increase until a tolerable muscle contraction and painless by the patient.

Locations

Country	Name	City	State
Spain	Lucía Inés Martínez Carnovale	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Terrassa

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Brescia MJ, Cimino JE, Appell K, Hurwich BJ, Scribner BH. Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. 1966. J Am Soc Nephrol. 1999 Jan;10(1):193-9. — View Citation

Fontseré N, Mestres G, Yugueros X, López T, Yuguero A, Bermudez P, Gomez F, Riambau V, Maduell F, Campistol JM. Effect of a postoperative exercise program on arteriovenous fistula maturation: A randomized controlled trial. Hemodial Int. 2016 Apr;20(2):306-14. doi: 10.1111/hdi.12376. Epub 2015 Oct 20. — View Citation

Leaf DA, MacRae HS, Grant E, Kraut J. Isometric exercise increases the size of forearm veins in patients with chronic renal failure. Am J Med Sci. 2003 Mar;325(3):115-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiocephalic fístula flow ( millimeters/minuts)		8 weeks ultrasonography parameter of maturation	Yes
Secondary	Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention		8 weeks	Yes