Neuromuscular Electrostimulation in Radiocephalic Fistula (NMS)

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

• 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

Study Overview

• Status: Unknown
• Conditions: Arteriovenous Fistula
• Intervention / Treatment: Device: Neuromuscular electrostimulation

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

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucía Inés Martínez Carnovale, MD; Phone Number: +340615950992; Email: luciaimartinez@hotmail.com
• Study Contact Backup: Name: Lucía Inés Martinez Carnovale, MD; Phone Number: +34 615950992; Email: luciaimartinez@hotmail.com

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08227
      • Recruiting
      • Lucía Inés Martínez Carnovale
      • Contact: Lucía Inés Martinez Carnovale, MD; Phone Number: +34 615950992; Email: luciaimartinez@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neuromuscular electrostimulation; Patients assigned to the group NMS, following the visit Day Hospital, in the first two hours of each HD session will perform a program of neuromuscular electrostimulation of the limb with the RC-AVF performed in the reference position of the flexors and extensors forearm at the tip intervened in each HD session on the stage previously established in the protocol (duration according to established program).	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.
NO_INTERVENTION: Isometric exercises; They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiocephalic fístula flow ( millimeters/minuts)	8 weeks ultrasonography parameter of maturation

Secondary Outcome Measures

Outcome Measure	Time Frame
Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention	8 weeks

Collaborators and Investigators

• Sponsor: Hospital de Terrassa
• Investigators: Principal Investigator: Lucía Inés Martínez Carnovale, MD, Hospital de Terrassa CST

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ANTICIPATED): November 1, 2016
• Study Completion (ANTICIPATED): January 1, 2017

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (ESTIMATE): October 6, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 6, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: VES-COMPAVI-2014-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO