Arteriovenous FistulaNMSNCT02925845
Neuromuscular Electrostimulation in Radiocephalic Fistula
A study testing Neuromuscular electrostimulation in people with Arteriovenous Fistula, run by Hospital de Terrassa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Neuromuscular electrostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Lucía Inés Martínez Carnovale
Terrassa, Barcelona, 08227
Lucía Inés Martinez Carnovale, MD, +34 615950992, luciaimartinez@hotmail.com
About this study
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
- 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
Read the 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
- Conditions
- Arteriovenous Fistula
- Being tested
- Neuromuscular electrostimulation
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrostimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrostimulation | Experimental | 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). Receives: Device: Neuromuscular electrostimulation |
| Isometric exercises | No intervention | They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiocephalic fístula flow ( millimeters/minuts)
Measured: 8 weeks ultrasonography parameter of maturation
Secondary outcomes (1)
Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionNov 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Martínez Carnovale, Hospital de Terrassa
- Investigators
- Lucía Inés Martínez Carnovale, MD, Principal investigator, Hospital de Terrassa CST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925845
- Sponsor's protocol ID
- VES-COMPAVI-2014-01
- Acronym
- NMS
- Status last verified
- Oct 2016
- First submitted
- 29 Sep 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 9890327Leaf 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.
PubMed 12640286Fontsere 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.
PubMed 26486682
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02925845
- Acronym / sponsor ID
- NMS / VES-COMPAVI-2014-01
- Conditions
- Arteriovenous Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hospital de TerrassaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrostimulation | Experimental | Device: Neuromuscular electrostimulationPatients 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). |
| Isometric exercises | No intervention | –They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrostimulationThe 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. | Device | Neuromuscular electrostimulation |
Primary outcome
Radiocephalic fístula flow ( millimeters/minuts)
Time frame: 8 weeks ultrasonography parameter of maturation
1 secondary outcome
Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Background: PubMed 9890327Brescia 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.
- Background: PubMed 12640286Leaf 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.
- Background: PubMed 26486682Fontsere 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucía Inés Martínez Carnovale, MD principal investigator
Hospital de Terrassa CST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrostimulation in people with Arteriovenous Fistula, run by Hospital de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucía Inés Martínez Carnovale, MD (+340615950992, luciaimartinez@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiocephalic fístula flow ( millimeters/minuts) (time frame: 8 weeks ultrasonography parameter of maturation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02925845, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.