Clinical trial NCT02925845: Neuromuscular Electrostimulation in Radiocephalic Fistula
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arteriovenous Fistula
Lead sponsor: Hospital de Terrassa
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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

Eligibility criteria: * 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

Primary outcomes:
measure: Radiocephalic fístula flow ( millimeters/minuts)
timeFrame: 8 weeks ultrasonography parameter of maturation
Secondary outcomes:
measure: Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Lucía Inés Martínez Carnovale
state: Barcelona
Study officials:
affiliation: Hospital de Terrassa CST
name: Lucía Inés Martínez Carnovale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.
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. doi: 10.1097/00000441-200303000-00003.
citation: Fontsere N, Mestres G, Yugueros X, Lopez 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.