Stenosis of Arteriovenous Dialysis FistulaNCT04399564
Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis
A study testing temporary hemodialysis catheters and long-term hemodialysis catheters in people with Stenosis of Arteriovenous Dialysis Fistula, run by Shanghai Pudong Hospital.
Trial summary
Vascular access (VA) is the most important for carrying out hemodialysis, yet it may bring in complications and leads to hemodialysis quality decline. This study aimed to explore the impact of vascular access types, including temporary vs.long term hemodialysis catheter on central vein stenosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stenosis of Arteriovenous Dialysis Fistula
- What is being tested?
- temporary hemodialysis catheters and long-term hemodialysis catheters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2021to 1 Jun 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- need to receive long-term hemodialysis no arteriovenous shunts or immature arteriovenous shunts
Who cannot join
- Uremia with heart failure or lung function failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis in Long-term Hemodialysis Patients
Vascular access (VA) is the most important for carrying out hemodialysis, yet it may bring in complications and leads to hemodialysis quality decline. This study aimed to explore the impact of vascular access types, including temporary vs.long term hemodialysis catheter on central vein stenosis.
Read the detailed description
It is unknown whether central vein stenosis occurs after temporary or long term hemodialysis catheter in long-term hemodialysis patients. this study will aim to explore this question. Study design is randomized, controlled trial. One arm is temporary catheters in the internal jugular vein, and another arm is tunneled cuffed hemodialysis cather. 2*2 is randomly distributed.
The main outcome: central vein stenosis diagnosed by venography. The secondary outcome: the time of infection, and catheter patency. Study period: one year
- Being tested
- temporary hemodialysis catheters, long-term hemodialysis catheters
- Keywords
- central vein stenosis, temporary hemodialysis catheters, long term hemodialysis catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporary hemodialysis cathetersDevice
Vascular access using temporary vs.long-term hemodialysis catheters
long-term hemodialysis cathetersDevice
long-term hemodialysis catheters
| Study group | Role | What they receive |
|---|---|---|
| temporary hemodialysis catheters | Active comparator | one arm-temporary hemodialysis catheter Receives: Device: temporary hemodialysis catheters |
| long-term hemodialysis catheters | Experimental | another arm-long term hemodialysis catheter Receives: Device: long-term hemodialysis catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
central vein stenosis
use of venography as the primary imaging modality for vein mapping
Measured: 8 weeks after temporary or long-term hemodialysis catheter
Secondary outcomes (2)
time of infection
infected in temporary or long-term hemodialysis catheters
Measured: 8 weeks
catheter unobstructed degree
blood flow in hemodialysis
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 posted22 May 2020
- Study start25 May 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis of Arteriovenous Dialysis 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
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Min Jin, MD, Principal investigator, Shanghai Pudong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399564
- Sponsor's protocol ID
- ShanghaiPudongH3
- Status last verified
- Mar 2021
- First submitted
- 15 May 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis in Long-term Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04399564
- Acronym / sponsor ID
- ShanghaiPudongH3
- Keywords
- central vein stenosis, temporary hemodialysis catheters, long term hemodialysis catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Study start
- 25 May 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 22 May 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.
Vascular access (VA) is the most important for carrying out hemodialysis, yet it may bring in complications and leads to hemodialysis quality decline. This study aimed to explore the impact of vascular access types, including temporary vs.long term hemodialysis catheter on central vein stenosis.
Detailed description
It is unknown whether central vein stenosis occurs after temporary or long term hemodialysis catheter in long-term hemodialysis patients. this study will aim to explore this question. Study design is randomized, controlled trial. One arm is temporary catheters in the internal jugular vein, and another arm is tunneled cuffed hemodialysis cather. 2*2 is randomly distributed.
The main outcome: central vein stenosis diagnosed by venography. The secondary outcome: the time of infection, and catheter patency. Study period: one year
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| temporary hemodialysis catheters | Active comparator | Device: temporary hemodialysis cathetersone arm-temporary hemodialysis catheter |
| long-term hemodialysis catheters | Experimental | Device: long-term hemodialysis cathetersanother arm-long term hemodialysis catheter |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- need to receive long-term hemodialysis no arteriovenous shunts or immature arteriovenous shunts
Key exclusion criteria (1 listed)
- Uremia with heart failure or lung function failure
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 |
|---|---|---|
| temporary hemodialysis cathetersVascular access using temporary vs.long-term hemodialysis catheters | Device | temporary hemodialysis catheters |
| long-term hemodialysis catheterslong-term hemodialysis catheters | Device | long-term hemodialysis catheters |
Primary outcome
central vein stenosis
Time frame: 8 weeks after temporary or long-term hemodialysis catheter
use of venography as the primary imaging modality for vein mapping
2 secondary outcomes
time of infection
Time frame: 8 weeks
catheter unobstructed degree
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 17 Mar 2021.
- 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.
Hui Min Jin, MD principal investigator
Shanghai Pudong Hospital
Questions about this trial
What is this clinical trial studying?
A study testing temporary hemodialysis catheters and long-term hemodialysis catheters in people with Stenosis of Arteriovenous Dialysis Fistula, run by Shanghai Pudong Hospital.
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 1 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Hui Min Jin, MD (13917232915, hmjgli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central vein stenosis (time frame: 8 weeks after temporary or long-term hemodialysis catheter). 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 17 Mar 2021.