End Stage Renal DiseaseENHANCENCT01597115
ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment
A study testing Duplex ultrasonography in people with End Stage Renal Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular access surgery with native vein for hemodialysis can increase the maturation rate of arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1 randomized study. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Duplex ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Sep 2014
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- end stage renal disease
- newly formed hemodialysis access with native vein
- 20~70 years
Who cannot join
- hemodialysis access surgery with ePTFE graft
- hemodialysis access surgery with basilic vein transposition
- hemodialysis access surgery with brachial vein transposition
- cephalic vein < 2.5mm in diameter
- radial artery diameter <2.0mm in radiocephalic arteriovenous fistula
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular access surgery with native vein for hemodialysis can increase the maturation rate of arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1 randomized study. Enrolled patients will be randomized as a control group (Physical exam at 2 and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4 weeks after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after surgery by duplex in all patients.
- Conditions
- End Stage Renal Disease
- Being tested
- Duplex ultrasonography
- Keywords
- duplex study, hemodialysis access, maturation rate, endovascular intervention
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex ultrasonographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Duplex | Active comparator | Patients in this group will be examed by duplex ultrasonography at 2 and 4 weeks after surgery Receives: Procedure: Duplex ultrasonography |
| physical exam | No intervention | According to the K/DOQI guideline, patients will be examed by vascular access surgeon at 2 and 4 weeks after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodialysis access maturation rate
Measured: 8 weeks after surgery
Secondary outcomes (1)
factors predicting maturation failure
Measured: 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang-Il Min, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597115
- Sponsor's protocol ID
- DUPLEX-IV-02-12
- Acronym
- ENHANCE
- Status last verified
- May 2014
- First submitted
- 10 May 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment
- ClinicalTrials.gov ID
- NCT01597115
- Acronym / sponsor ID
- ENHANCE / DUPLEX-IV-02-12
- Conditions
- End Stage Renal Disease
- Keywords
- duplex study, hemodialysis access, maturation rate, endovascular intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 May 2012 (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.
The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular access surgery with native vein for hemodialysis can increase the maturation rate of arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1 randomized study. Enrolled patients will be randomized as a control group (Physical exam at 2 and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4 weeks after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after surgery by duplex in all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duplex | Active comparator | Procedure: Duplex ultrasonographyPatients in this group will be examed by duplex ultrasonography at 2 and 4 weeks after surgery |
| physical exam | No intervention | –According to the K/DOQI guideline, patients will be examed by vascular access surgeon at 2 and 4 weeks after surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- end stage renal disease
- newly formed hemodialysis access with native vein
- 20~70 years
Key exclusion criteria (5 listed)
- hemodialysis access surgery with ePTFE graft
- hemodialysis access surgery with basilic vein transposition
- hemodialysis access surgery with brachial vein transposition
- cephalic vein < 2.5mm in diameter
- radial artery diameter <2.0mm in radiocephalic arteriovenous fistula
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 |
|---|---|---|
| Duplex ultrasonography | Procedure or surgery | Duplex |
Primary outcome
hemodialysis access maturation rate
Time frame: 8 weeks after surgery
1 secondary outcome
factors predicting maturation failure
Time frame: 8 weeks after surgery
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 27 May 2015.
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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.
Sang-Il Min, MD principal investigator
Seoul National University 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 Duplex ultrasonography in people with End Stage Renal Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 5 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 27 May 2015. 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 South Korea. 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?
hemodialysis access maturation rate (time frame: 8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2015.