Hemodialysis Access FailureNCT04416971
Clinical Values of Mature Fistulas in Hemodialysis
An observational study of Hemodialysis Access Failure and Hemodialysis Complication, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis(HD), and fistula-first is the general recommendation for all HD patients. But in clinical practice in China, quite a few patients start HD before AVF maturation due to various situations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis Access Failure, Hemodialysis Complication
- What is being tested?
- AVF puncture
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2020to 20 Nov 2021
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * aged 18 years and older * underwent initial upper-extremity AVF creation for incident HD at our hospital * divided into mature/immature AVF groups according to the AVF status on HD initiation
Who may be able to join
- underwent initial upper-extremity AVF creation for incident HD at Zhongshan Hospital, Fudan University
Who cannot join
- with malignancies
- not followed-up at Zhongshan Hospital, Fudan University
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
No.180, Fenglin Road, Xuhui District
Shanghai, Shanghai Municipality, 200032
wenlv lv, MD, lv.wenlv@zs-hospital.sh.cn
About this study
The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis(HD), and fistula-first is the general recommendation for all HD patients. But in clinical practice in China, quite a few patients start HD before AVF maturation due to various situations. Whether HD initiation with mature AVF will influence the patency and complications is controversial. This study is aim to compare the AVF patency in incident HD patients with mature or immature AVF on HD initiation, and to compare other clinical outcomes, including abandonment without use, infection, and other AVF complications occurrence.
- Being tested
- AVF puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVF punctureProcedure or surgery
For patients with mature/immature AVF on HD initiation, AVF puncture will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| mature AVF | Patients initiate HD with mature AVF. Receives: Procedure: AVF puncture | |
| immature AVF | Patients initiate HD with immature AVF. Receives: Procedure: AVF puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
AVF patency
A functional AVF was defined as allowing at least six adequate HD sessions without any AVF-related complications. Primary AVF patency was defined as the interval from HD initiation via a functional AVF to any intervention designed for maintenance or reestablishment of AVF function, AVF failure, or study end, whichever occurred first, and secondary AVF patency was defined as the interval from HD initiation via an AVF until the termination of HD via AVF due to any cause, regardless of the number of subsequent interventions.
Measured: June 2020 to June 2021
Secondary outcomes (1)
Abandonment without use, infection, and other complications of AVF creation.
Abandonment without use, infection, and other complications of AVF creation.
Measured: June 2020 to June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start20 Aug 2020 (estimated)
- Primary completion20 Aug 2021 (estimated)
- Study completion20 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Access FailureStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Shen, Shanghai Zhongshan Hospital
- Investigators
- bo shen, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416971
- Sponsor's protocol ID
- Mature Fistulas
- Status last verified
- Aug 2020
- First submitted
- 1 Jun 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Values of Mature Fistulas in Hemodialysis
- ClinicalTrials.gov ID
- NCT04416971
- Acronym / sponsor ID
- Mature Fistulas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 20 Aug 2020 (estimated)
- Primary completion
- 20 Aug 2021 (estimated)
- Study completion
- 20 Nov 2021 (estimated)
- First posted
- 4 Jun 2020 (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.
The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis(HD), and fistula-first is the general recommendation for all HD patients. But in clinical practice in China, quite a few patients start HD before AVF maturation due to various situations. Whether HD initiation with mature AVF will influence the patency and complications is controversial. This study is aim to compare the AVF patency in incident HD patients with mature or immature AVF on HD initiation, and to compare other clinical outcomes, including abandonment without use, infection, and other AVF complications occurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mature AVF | – | Procedure: AVF puncturePatients initiate HD with mature AVF. |
| immature AVF | – | Procedure: AVF puncturePatients initiate HD with immature AVF. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * aged 18 years and older * underwent initial upper-extremity AVF creation for incident HD at our hospital * divided into mature/immature AVF groups according to the AVF status on HD initiation
Key inclusion criteria (1 listed)
- underwent initial upper-extremity AVF creation for incident HD at Zhongshan Hospital, Fudan University
Key exclusion criteria (2 listed)
- with malignancies
- not followed-up at Zhongshan Hospital, Fudan University
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 |
|---|---|---|
| AVF punctureFor patients with mature/immature AVF on HD initiation, AVF puncture will be conducted. | Procedure or surgery | immature AVF, mature AVF |
Primary outcome
AVF patency
Time frame: June 2020 to June 2021
A functional AVF was defined as allowing at least six adequate HD sessions without any AVF-related complications. Primary AVF patency was defined as the interval from HD initiation via a functional AVF to any intervention designed for maintenance or reestablishment of AVF function, AVF failure, or study end, whichever occurred first, and secondary AVF patency was defined as the interval from HD initiation via an AVF until the termination of HD via AVF due to any cause, regardless of the number of subsequent interventions.
1 secondary outcome
Abandonment without use, infection, and other complications of AVF creation.
Time frame: June 2020 to June 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- 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.
bo shen, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis Access Failure and Hemodialysis Complication, run by Shanghai Zhongshan Hospital 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 1 inclusion and 2 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 18 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bo shen, MD (+86-13795307471, shen.bo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AVF patency (time frame: June 2020 to June 2021). 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 18 Aug 2020.