Arteriovenous FistulaNCT01642459
The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.
A study testing Same direction cannulation and Opposite direction cannulation in people with Arteriovenous Fistula, run by Dongliang Zhang, MD at 1 site in China.
Trial summary
The investigators hypothesis that aneurysms and stenoses will be decreased if the direction of inserted arterial needle were same as the direction of blood flow, when compared to the opposite direction puncture. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Same direction cannulation and Opposite direction cannulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Apr 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MHD patients with autogenous AVF.
- Newly setup AVF in 3 months.
- Fore- or Upper arm AVF.
- Flow of >800ml/min detected by using the ultrasound dilution technique.
Who cannot join
- AVF after neoplasty.
- Arteriovenous grafts.
- Anticipated live time less than one year.
- Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Outcomes of Arteriovenous Fistula (AVF) Cannulated From Different Direction in Maintenance Hemodialysis Patients.
The investigators hypothesis that aneurysms and stenoses will be decreased if the direction of inserted arterial needle were same as the direction of blood flow, when compared to the opposite direction puncture.
Read the detailed description
Native arteriovenous fistula (AVF) is the preferred access for hemodialysis, and cannulation technique is very important factors affect the outcomes of AVF. Rope-ladder cannulation is one kind of the standard puncture techniques which is used commonly in maintenance hemodialysis (MHD) patients. There are many complications for rope-ladder cannulation, such as venous aneurysm and vascular stenosis, which may induce AVF dysfunction. For the venous outflow way, there always be aneurysm followed by stenoses at the sites of needle connected with the arterial line in rope-ladder cannulation patients. The investigators hypothesis that the directions of inserted arterial needles should affect the AVF outcomes. The present prospective study will compare the outcomes of AVF between the puncture direction at arterial needle sites same as blood flow and opposite to blood flow.
- Conditions
- Arteriovenous Fistula
- Being tested
- Same direction cannulation, Opposite direction cannulation
- Keywords
- arteriovenous fistula, hemodialysis, aneurysm, vascular stenosis, cannulation
- Medical subject headings
- Arteriovenous Fistula, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same direction cannulationOther
The puncture direction of the arterial needle is same as the blood flow in every hemodialysis session.
Opposite direction cannulationOther
The puncture direction of the arterial needle is opposite to the blood flow in every hemodialysis session.
| Study group | Role | What they receive |
|---|---|---|
| Same direction cannulation | Experimental | The inserted direction of arterial needle is same as the direction of blood flow. Receives: Other: Same direction cannulation |
| Opposite direction cannulation | Active comparator | The inserted direction of arterial needle is opposite to the direction of blood flow. Receives: Other: Opposite direction cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of AVF aneurysm and stenosis.
Compare the prevalence of AVF aneurysm and stenosis between two groups during 12 months.
Measured: 12 months
Secondary outcomes (5)
Proportions of AVF dysfunction in different groups.
Compare the proportions of AVF dysfunction between two groups during 12 months.
Measured: 12 months
The size of venous aneurysm.
Measure the maximum size of venous aneurysm by using ultrasonography at month 12.
Measured: 12 months
Diameter of venous stenosis.
Measure the minimum diameter of venous stenosis by ultrasonography at month 12.
Measured: 12 months
Percentages of unsuccessful cannulations.
Unsuccessful cannulations include mis-cannulation, cannulation ease, hematoma, more than once cannulation at arterial site.
Measured: 12 months
Events of AVF obstruction.
AVF obstruction and the following treatments as central venous catheters and interventions will be recorded and compared between two groups during 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: The patients enrolled are limited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongliang Zhang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongliang Zhang, MD, Capital Medical University
- Investigators
- Dongliang Zhang, Doctor, Study chair, Kidney Disease Faculty of Capital Medical UniversityWenying Cui, Bachelor, Study director, Nephrology Department of Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642459
- Sponsor's protocol ID
- 2012-0107
- Status last verified
- May 2015
- First submitted
- 12 Jul 2012
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Arteriovenous Fistula (AVF) Cannulated From Different Direction in Maintenance Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT01642459
- Acronym / sponsor ID
- 2012-0107
- Conditions
- Arteriovenous Fistula
- Keywords
- arteriovenous fistula, hemodialysis, aneurysm, vascular stenosis, cannulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The patients enrolled are limited.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dongliang Zhang, MDUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Jul 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 investigators hypothesis that aneurysms and stenoses will be decreased if the direction of inserted arterial needle were same as the direction of blood flow, when compared to the opposite direction puncture.
Detailed description
Native arteriovenous fistula (AVF) is the preferred access for hemodialysis, and cannulation technique is very important factors affect the outcomes of AVF. Rope-ladder cannulation is one kind of the standard puncture techniques which is used commonly in maintenance hemodialysis (MHD) patients. There are many complications for rope-ladder cannulation, such as venous aneurysm and vascular stenosis, which may induce AVF dysfunction. For the venous outflow way, there always be aneurysm followed by stenoses at the sites of needle connected with the arterial line in rope-ladder cannulation patients. The investigators hypothesis that the directions of inserted arterial needles should affect the AVF outcomes. The present prospective study will compare the outcomes of AVF between the puncture direction at arterial needle sites same as blood flow and opposite to blood flow.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same direction cannulation | Experimental | Other: Same direction cannulationThe inserted direction of arterial needle is same as the direction of blood flow. |
| Opposite direction cannulation | Active comparator | Other: Opposite direction cannulationThe inserted direction of arterial needle is opposite to the direction of blood flow. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MHD patients with autogenous AVF.
- Newly setup AVF in 3 months.
- Fore- or Upper arm AVF.
- Flow of >800ml/min detected by using the ultrasound dilution technique.
Key exclusion criteria (4 listed)
- AVF after neoplasty.
- Arteriovenous grafts.
- Anticipated live time less than one year.
- Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
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 |
|---|---|---|
| Same direction cannulationThe puncture direction of the arterial needle is same as the blood flow in every hemodialysis session. | Other | Same direction cannulation |
| Opposite direction cannulationThe puncture direction of the arterial needle is opposite to the blood flow in every hemodialysis session. | Other | Opposite direction cannulation |
Primary outcome
Prevalence of AVF aneurysm and stenosis.
Time frame: 12 months
Compare the prevalence of AVF aneurysm and stenosis between two groups during 12 months.
5 secondary outcomes
Proportions of AVF dysfunction in different groups.
Time frame: 12 months
The size of venous aneurysm.
Time frame: 12 months
Diameter of venous stenosis.
Time frame: 12 months
Percentages of unsuccessful cannulations.
Time frame: 12 months
Events of AVF obstruction.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The patients enrolled are limited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
Related trials for Arteriovenous Fistula
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Not yet recruiting
DialysisBot: AI Chatbot for Hemodialysis Self-Management
Chatbot-Based Training, Hemodialysis
RecruitingObservational study
NAIF 2.0 - COGNIFY
Dural Arteriovenous Fistula, Glymphatic System
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.
Dongliang Zhang, Doctor study chair
Kidney Disease Faculty of Capital Medical University
Wenying Cui, Bachelor study director
Nephrology Department of Beijing Friendship 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 Same direction cannulation and Opposite direction cannulation in people with Arteriovenous Fistula, run by Dongliang Zhang, MD at 1 site in China.
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: stopped early, as of the sponsor's last update on 20 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 China. 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 was stopped early (reason given: The patients enrolled are limited.). Results are not available in the source record.
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?
Prevalence of AVF aneurysm and stenosis. (time frame: 12 months). 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 20 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.