Arteriovenous Fistula ThrombosisPHYSICALFAVNCT03213756
Isometric Preoperative Exercise on Autologous Arteriovenous Fistulas. Randomized Clinical Trial
A study testing Isometric exercises using Hand grip and elastic bands in people with Arteriovenous Fistula Thrombosis and Arteriovenous Fistula Stenosis, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
A good vascular access (VA) is vital for hemodialysis (HD) patients. The start of HD with autologous arteriovenous fistula (AVF) means higher survival, lower sanitary costs and complications. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Arteriovenous Fistula Thrombosis, Arteriovenous Fistula Stenosis
- What is being tested?
- Isometric exercises using Hand grip and elastic bands
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jul 2017to 30 Oct 2019
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signature.
- Age between 18 and 89 years.
- Patients with advanced chronic kidney disease, stages IV-V, in pre-dialysis or prevalent HD patients, requiring new AVF.
Who cannot join
- Absence of adequate arteries and veins to allow autologous AVF. (The minimum gauges that will be considered in order to perform an autologous AVF are: artery caliber equal or greater than 1.6 mm and vein caliber equal or greater than 1,8 mm with a compressor).
- Diagnosis of coagulopathy or hemoglobinopathy of any cause.
- Patients who urgently need an AVF without the possibility of being 8 weeks on the surgical waiting list.
- Impossibility to perform the physical exercise protocol due to physical or mental disabilities or lack of social support.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Isometric Preoperative Exercise on Vascular Caliber and the Maturation of Autologous Arteriovenous Fistulas. Randomized Clinical Trial
A good vascular access (VA) is vital for hemodialysis (HD) patients. The start of HD with autologous arteriovenous fistula (AVF) means higher survival, lower sanitary costs and complications. The distal forearm AVF is known as the best option but not all patients are good candidates for this surgery, and there is a primary failure rate between 20 and 50% published in literature.
The choice of the optimal AVF for each patient is conditioned mainly by the anatomical and hemodynamic characteristics of the artery and the vein chosen to perform the anastomosis. These characteristics can be modified by performing physical exercise Some vascular access guidelines suggest the performance of isometric exercises in the pre and postoperative period of the AVF confection. However, there is very little data in literature on the possible efficacy of preoperative exercise, although small published observational studies point to an improvement in the venous and arterial caliber. Regarding the postoperative exercises, they do seem to improve maturation, however the degree of evidence in literature is low and there is no consensus on the exercise protocol to follow.
We present an open-label, multicenter, prospective, controlled and randomized study in order to evaluate the usefulness of preoperative isometric exercise (PIE) in pre-dialysis patients or in prevalent HD with indication of performing a new AVF. The randomization will be 1: 1, one group of patients will perform PIE for 8 weeks and the other group of patients will be a control group. The main purpose will be to evaluate if there is a lower rate of primary failure in the PIE group compared with control group.
Read the detailed description
RECRUITING PERIOD: 20 months.
FOLLOW UP: From the first preoperative assessment visit for AVF up to 3 months after its creation.
METHODS:
After signing the informed consent, patients will be randomized through a centralized computer program to one of two groups of patients, PIE group versus control group.
In both groups of patients, a first physical examination of upper arm extremities and an initial doppler ultrasound will be performed, evaluating the anatomical and hemodynamic characteristics of the arteries and veins of both arms. At that time, a first surgical option of AVF will be indicated.
In the PIE group, the patients will receive detailed information about the daily preoperative exercise protocol and they will perform this protocol for at least six and ideally more than eight weeks based on:
- Isometric exercise using hand-grip. This exercise consists of two sets of 30 hand-grip contractions with the hand of the upper arm candidate for AVF (in case of doubts about the most appropriate arm for AVF the exercise will be performed with both arms). The patient will rest one minute every 10 contractions and 5 minutes between both sets. The patient will repeat this protocol twice a day, morning and night (Approximately 15 minutes each session). The contraction intensity will start with half of the maximum force obtained by dynamometry and will be increased or decreased to be placed on an effort intensity 2-3 in the Borg scale.
- Isometric exercise using elastic bands. At noon the patient will perform a slow contraction session using elastic band with 20 slow repetitions with the arm in flexion and 20 repetitions with the arm in extension. (Total duration: less than 10 minutes) Clinical follow-up of these patients will be fortnightly to ensure that they perform the exercises correctly and to measure the force acquired through dynamometry. Likewise, brachial diameter and bicipital and tricipital skinfolds will be measured. In addition, they will be contacted by telephone once a week to assess compliance. Doppler ultrasonography will be performed at the initial visit, and at 4 and 8 week-visits (visits 1, 2 and 3). In the doppler ultrasound performed at 8 weeks, the final surgical indication will be given depending on the caliber of the vessels in the chosen arm. At the initial visit and at the 8-week visit, biological samples will be obtained to assess the parameters of nutrition and muscle mass and a bioimpedanciometry will be performed.
The date of surgery will be coordinated with anesthesia and peripheral vascular surgery services to program the intervention during the fortnight after the 8-week isometric exercise period (weeks 9-10). In prevalent HD patients with central venous catheter (CVC) presenting greater urgency of AVF, surgery will be scheduled between the 6 and 8 week of exercises.
Control group patients will follow the usual surgical waiting list protocol (Estimated 1,5-2 months). Baseline and preoperative ultrasonography will also be performed in these patients, in which it will be verified that there are no significant changes in vascular mapping (punctures sites, hematomas, etc.) and the indication of AVF performed in the initial visit will be confirmed. Dynamometry, bicipital and tricipital skinfolds measurement, brachial diameter, analytical parameters of nutrition and muscle mass and bioimpedanciometry will be performed both at the onset visit and at the preoperative visit. The only difference with PIE group is the 4 weeks follow-up ultrasound that will not be performed in control group.
After the AVF creation the maturation will be monitored with doppler ultrasound at 1, 6 and 12 weeks after the surgery (visits 4, 5 and 6) and the usual postoperative isometric exercise with ball contraction will be recommended to all patients. Follow-up will be completed three months after the surgical procedure, defining whether the AVF has matured or if there has been a primary failure.
FOLLOW-UP LOSSES:
- Abandonment or withdrawal of informed consent.
- Transplant.
- Change of dialysis technique.
- Transfer to another center.
- Exitus.
- Being tested
- Isometric exercises using Hand grip and elastic bands
- Keywords
- doppler ultrasound, physical exercise, arteriovenous fistula maturation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exercises using Hand grip and elastic bandsDevice
- Isometric exercises using hand-grip. This exercise consists of two sets of 30 hand-grip contractions with the hand of the upper arm candidate for AVF (in case of doubts about the most appropriate arm for AVF the exercise will be performed with both arms). The patient will rest one minute every 10 contractions and 5 minutes between both sets. The patient will repeat this protocol twice a day, morning and night (Approximately 15 minutes each session). The contraction intensity will start with half of the maximum force obtained by dynamometry and will be increased or decreased to be placed on an effort intensity 2-3 in the Borg scale.
- Isometric exercise using elastic bands. At noon the patient will perform a slow contraction session using elastic band with 20 slow repetitions with the arm in flexion and 20 repetitions with the arm in extension. (Total duration: less than 10 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Preoperative isometric exercise (PIE) group | Experimental | In the PIE group, the patients will perform daily preoperative exercise protocol based on isometric exercises using hand grip and elastic bands. They will perform this protocol for at least six and ideally eight weeks before surgery. Receives: Device: Isometric exercises using Hand grip and elastic bands |
| Control group | No intervention | Control group patients will follow the usual surgical waiting list protocol (Estimated 1,5-2 months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of PIE on AVF primary failure comparing the control group and the PIE group.
We will evaluate in both groups the primary failure rate. It will be evaluated during visit 6 (12 weeks after AVF creation). We expect a lower primary failure rate in the PIE group.
Measured: 12 weeks after AVF surgery (visit 6)
Secondary outcomes (5)
Percentage of candidate patients for autologous distal or proximal AVF in both groups.
We will evaluate how many distal or proximal AVFs we perform in both groups. We expect an increase in the percentage of distal AVF in the PIE group
Measured: 1 week after AVF surgery (visit 4)
Differences on the caliber of upper arm arteries and veins in the PIE group before and after isometric exercise.
Caliber, resistance index and flow of radial and brachial arteries and caliber of cephalic and basilic veins wil be measured in both groups using doppler ultrasound. We expect to find an increase in the diameters of arteries and veins in PIE group.
Measured: 8 weeks follow up visit before surgery (visit 3)
Impact of AVF evaluation with doppler ultrasound in the postoperative period in both groups, adding the usual isometric exercise with ball contraction in all patients.
This study will allow to protocolize the AVF maturation surveillance with Doppler ultrasound in all participating centers, with early detection of stenosis and optimization of the primary assisted patency of AVF in our patients.
Measured: 12 weeks after AVF surgery (visit 6)
Analysis of the optimal arterial and venous calibres to minimize the primary failure of AVF according to the individual risk factors in both groups of patients.
We will correlate the characteristics of arteria and vein and comorbidities of the patients with the AVFs outcomes in both groups in order to find the optimal characteristics of arteria and vein to perform an adequate AVF
Measured: 12 weeks after AVF surgery (visit 6)
Impact of nutritional-inflammatory status on AVF outcomes
We will study if there is any correlation between nutritional-inflammatory status of the patients included in both groups and the AVF outcomes.
The nutritional-inflammatory status will be evaluated with clinical and biochemical parameters, including endothelial disfunction biomarkers.
Measured: 12 weeks after AVF surgery (visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start18 Jul 2017
- Primary completion31 Jul 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous Fistula ThrombosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, prospective, controlled, randomized, multicenter study in parallel groups, where in the preoperative AVF period, one group of patients will perform an isometric exercise protocol for 8 weeks and will be compared with a control group of patients that will not perform this preoperative exercise
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Nephrology
- Responsible party
- Principal investigator, Ines Aragoncillo, Hospital General Universitario Gregorio Marañon
- Investigators
- INES ARAGONCILLO, MD, Principal investigator, GREGORIO MARAÑON HOSPITALALMUDENA VEGA, MD PHD, Study chair, GREGORIO MARAÑON HOSPITALSORAYA ABAD, MD, Study chair, GREGORIO MARAÑON HOSPITALNICOLAS MACIAS, MD, Study chair, GREGORIO MARAÑON HOSPITALJOSE MANUEL LIGERO, MD, Study chair, GREGORIO MARAÑON HOSPITALROSARIO GARCIA PAJARES, MD, Study chair, GREGORIO MARAÑON HOSPITALANGEL LUIS MORALES, MD, Study chair, GREGORIO MARAÑON HOSPITALTERESA CERVERA, MD, Study chair, GREGORIO MARAÑON HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213756
- Sponsor's protocol ID
- PHYSICALFAV
- Other IDs
- PHYSICALFAV, PHYSICALFAV
- Acronym
- PHYSICALFAV
- Status last verified
- Mar 2020
- First submitted
- 29 Jun 2017
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary and secondary outcome results will be included in the web site with in 12 month from the end of the study
Publications
Nantakool S, Reanpang T, Prasannarong M, Pongtam S, Rerkasem K. Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013327. doi: 10.1002/14651858.CD013327.pub2.
PubMed 36184076
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isometric Preoperative Exercise on Vascular Caliber and the Maturation of Autologous Arteriovenous Fistulas. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03213756
- Acronym / sponsor ID
- PHYSICALFAV / PHYSICALFAV
- Keywords
- doppler ultrasound, physical exercise, arteriovenous fistula maturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Spanish Society of Nephrology
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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.
A good vascular access (VA) is vital for hemodialysis (HD) patients. The start of HD with autologous arteriovenous fistula (AVF) means higher survival, lower sanitary costs and complications. The distal forearm AVF is known as the best option but not all patients are good candidates for this surgery, and there is a primary failure rate between 20 and 50% published in literature.
The choice of the optimal AVF for each patient is conditioned mainly by the anatomical and hemodynamic characteristics of the artery and the vein chosen to perform the anastomosis. These characteristics can be modified by performing physical exercise Some vascular access guidelines suggest the performance of isometric exercises in the pre and postoperative period of the AVF confection. However, there is very little data in literature on the possible efficacy of preoperative exercise, although small published observational studies point to an improvement in the venous and arterial caliber. Regarding the postoperative exercises, they do seem to improve maturation, however the degree of evidence in literature is low and there is no consensus on the exercise protocol to follow.
We present an open-label, multicenter, prospective, controlled and randomized study in order to evaluate the usefulness of preoperative isometric exercise (PIE) in pre-dialysis patients or in prevalent HD with indication of performing a new AVF. The randomization will be 1: 1, one group of patients will perform PIE for 8 weeks and the other group of patients will be a control group. The main purpose will be to evaluate if there is a lower rate of primary failure in the PIE group compared with control group.
Detailed description
RECRUITING PERIOD: 20 months.
FOLLOW UP: From the first preoperative assessment visit for AVF up to 3 months after its creation.
METHODS:
After signing the informed consent, patients will be randomized through a centralized computer program to one of two groups of patients, PIE group versus control group.
In both groups of patients, a first physical examination of upper arm extremities and an initial doppler ultrasound will be performed, evaluating the anatomical and hemodynamic characteristics of the arteries and veins of both arms. At that time, a first surgical option of AVF will be indicated.
In the PIE group, the patients will receive detailed information about the daily preoperative exercise protocol and they will perform this protocol for at least six and ideally more than eight weeks based on:
- Isometric exercise using hand-grip. This exercise consists of two sets of 30 hand-grip contractions with the hand of the upper arm candidate for AVF (in case of doubts about the most appropriate arm for AVF the exercise will be performed with both arms). The patient will rest one minute every 10 contractions and 5 minutes between both sets. The patient will repeat this protocol twice a day, morning and night (Approximately 15 minutes each session). The contraction intensity will start with half of the maximum force obtained by dynamometry and will be increased or decreased to be placed on an effort intensity 2-3 in the Borg scale.
- Isometric exercise using elastic bands. At noon the patient will perform a slow contraction session using elastic band with 20 slow repetitions with the arm in flexion and 20 repetitions with the arm in extension. (Total duration: less than 10 minutes) Clinical follow-up of these patients will be fortnightly to ensure that they perform the exercises correctly and to measure the force acquired through dynamometry. Likewise, brachial diameter and bicipital and tricipital skinfolds will be measured. In addition, they will be contacted by telephone once a week to assess compliance. Doppler ultrasonography will be performed at the initial visit, and at 4 and 8 week-visits (visits 1, 2 and 3). In the doppler ultrasound performed at 8 weeks, the final surgical indication will be given depending on the caliber of the vessels in the chosen arm. At the initial visit and at the 8-week visit, biological samples will be obtained to assess the parameters of nutrition and muscle mass and a bioimpedanciometry will be performed.
The date of surgery will be coordinated with anesthesia and peripheral vascular surgery services to program the intervention during the fortnight after the 8-week isometric exercise period (weeks 9-10). In prevalent HD patients with central venous catheter (CVC) presenting greater urgency of AVF, surgery will be scheduled between the 6 and 8 week of exercises.
Control group patients will follow the usual surgical waiting list protocol (Estimated 1,5-2 months). Baseline and preoperative ultrasonography will also be performed in these patients, in which it will be verified that there are no significant changes in vascular mapping (punctures sites, hematomas, etc.) and the indication of AVF performed in the initial visit will be confirmed. Dynamometry, bicipital and tricipital skinfolds measurement, brachial diameter, analytical parameters of nutrition and muscle mass and bioimpedanciometry will be performed both at the onset visit and at the preoperative visit. The only difference with PIE group is the 4 weeks follow-up ultrasound that will not be performed in control group.
After the AVF creation the maturation will be monitored with doppler ultrasound at 1, 6 and 12 weeks after the surgery (visits 4, 5 and 6) and the usual postoperative isometric exercise with ball contraction will be recommended to all patients. Follow-up will be completed three months after the surgical procedure, defining whether the AVF has matured or if there has been a primary failure.
FOLLOW-UP LOSSES:
- Abandonment or withdrawal of informed consent.
- Transplant.
- Change of dialysis technique.
- Transfer to another center.
- Exitus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, prospective, controlled, randomized, multicenter study in parallel groups, where in the preoperative AVF period, one group of patients will perform an isometric exercise protocol for 8 weeks and will be compared with a control group of patients that will not perform this preoperative exercise
| Arm | Type | Receives |
|---|---|---|
| Preoperative isometric exercise (PIE) group | Experimental | Device: Isometric exercises using Hand grip and elastic bandsIn the PIE group, the patients will perform daily preoperative exercise protocol based on isometric exercises using hand grip and elastic bands. They will perform this protocol for at least six and ideally eight weeks before surgery. |
| Control group | No intervention | –Control group patients will follow the usual surgical waiting list protocol (Estimated 1,5-2 months). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent signature.
- Age between 18 and 89 years.
- Patients with advanced chronic kidney disease, stages IV-V, in pre-dialysis or prevalent HD patients, requiring new AVF.
Key exclusion criteria (4 listed)
- Absence of adequate arteries and veins to allow autologous AVF. (The minimum gauges that will be considered in order to perform an autologous AVF are: artery caliber equal or greater than 1.6 mm and vein caliber equal or greater than 1,8 mm with a compressor).
- Diagnosis of coagulopathy or hemoglobinopathy of any cause.
- Patients who urgently need an AVF without the possibility of being 8 weeks on the surgical waiting list.
- Impossibility to perform the physical exercise protocol due to physical or mental disabilities or lack of social support.
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 |
|---|---|---|
| Isometric exercises using Hand grip and elastic bands* Isometric exercises using hand-grip. This exercise consists of two sets of 30 hand-grip contractions with the hand of the upper arm candidate for AVF (in case of doubts about the most appropriate arm for AVF the exercise will be performed with both arms). The patient will rest one minute every 10 contractions and 5 minutes between both sets. The patient will repeat this protocol twice a day, morning and night (Approximately 15 minutes each session). The contraction intensity will start with half of the maximum force obtained by dynamometry and will be increased or decreased to be placed on an effort intensity 2-3 in the Borg scale. * Isometric exercise using elastic bands. At noon the patient will perform a slow contraction session using elastic band with 20 slow repetitions with the arm in flexion and 20 repetitions with the arm in extension. (Total duration: less than 10 minutes) | Device | Preoperative isometric exercise (PIE) group |
Primary outcome
Impact of PIE on AVF primary failure comparing the control group and the PIE group.
Time frame: 12 weeks after AVF surgery (visit 6)
We will evaluate in both groups the primary failure rate. It will be evaluated during visit 6 (12 weeks after AVF creation). We expect a lower primary failure rate in the PIE group.
5 secondary outcomes
Percentage of candidate patients for autologous distal or proximal AVF in both groups.
Time frame: 1 week after AVF surgery (visit 4)
Differences on the caliber of upper arm arteries and veins in the PIE group before and after isometric exercise.
Time frame: 8 weeks follow up visit before surgery (visit 3)
Impact of AVF evaluation with doppler ultrasound in the postoperative period in both groups, adding the usual isometric exercise with ball contraction in all patients.
Time frame: 12 weeks after AVF surgery (visit 6)
Analysis of the optimal arterial and venous calibres to minimize the primary failure of AVF according to the individual risk factors in both groups of patients.
Time frame: 12 weeks after AVF surgery (visit 6)
Impact of nutritional-inflammatory status on AVF outcomes
Time frame: 12 weeks after AVF surgery (visit 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Derived from this study: PubMed 36184076Nantakool S, Reanpang T, Prasannarong M, Pongtam S, Rerkasem K. Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013327. doi: 10.1002/14651858.CD013327.pub2.
- Individual participant dataSharing planned: Yes. Primary and secondary outcome results will be included in the web site with in 12 month from the end of the study
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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.
INES ARAGONCILLO, MD principal investigator
GREGORIO MARAÑON HOSPITAL
ALMUDENA VEGA, MD PHD study chair
GREGORIO MARAÑON HOSPITAL
SORAYA ABAD, MD study chair
GREGORIO MARAÑON HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercises using Hand grip and elastic bands in people with Arteriovenous Fistula Thrombosis and Arteriovenous Fistula Stenosis, run by Hospital General Universitario Gregorio Marañon 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 3 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: finished, as of the sponsor's last update on 6 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of PIE on AVF primary failure comparing the control group and the PIE group. (time frame: 12 weeks after AVF surgery (visit 6)). 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 NCT03213756, which also lists 1 linked publication.
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 Mar 2020.