End Stage Renal DiseaseACCESS-ChinaNCT02272374
Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China
A study testing AVF creation, TCC placement and AVG creation in people with End Stage Renal Disease, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
The purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous graft) in the elderly and very elderly with end-stage renal disease in China. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- AVF creation, TCC placement and AVG creation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The elderly and very elderly with end stage renal disease.
- Estimated glomerular filtration rate (eGFR) <20ml/min*1.73m2
- All study subjects agree to participate in the study and provide written informed consent.
Who cannot join
- Patients' life expectancy is less than 2 years.
- Mental illness that makes the patients unable to complete the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China :a Multicenter Prospective Cohort Study
The purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous graft) in the elderly and very elderly with end-stage renal disease in China.
- Conditions
- End Stage Renal Disease
- Being tested
- AVF creation, TCC placement, AVG creation
- Keywords
- Hemodialysis, Arteriovenous fistula, Tunneled cuffed catheter, Arteriovenous graft, Elderly, Very elderly
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVF creationProcedure or surgery
Also called Arteriovenous fistula creation
TCC placementProcedure or surgery
Also called Tunneled cuffed catheter placement
AVG creationProcedure or surgery
Also called Arteriovenous graft creation
| Study group | Role | What they receive |
|---|---|---|
| e-AVF group | Experimental | 120 elderly with end stage renal disease will undergo AVF creation. Receives: Procedure: AVF creation |
| e-TCC group | Experimental | 120 elderly with end stage renal disease will undergo TCC placement. Receives: Procedure: TCC placement |
| e-AVG group | Experimental | 60 elderly with end stage renal disease will undergo AVG creation. Receives: Procedure: AVG creation |
| ve-AVF group | Experimental | 80 very elderly with end stage renal disease will undergo AVF creation. Receives: Procedure: AVF creation |
| ve-TCC group | Experimental | 80 very elderly with end stage renal disease will undergo TCC placement. Receives: Procedure: TCC placement |
| ve-AVG group | Experimental | 40 very elderly with end stage renal disease will undergo AVG creation. Receives: Procedure: AVG creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patency rate of vascular access
Including primary and secondary patency rate.Blood flow can be above 500 mL/min in a mature arteriovenous fistula by ultrasound scan and 4 times of body weight (Kg*4 mL/min) in a arteriovenous graft or tunneled cuffed catheter in dialysis practice.
Measured: 2 years
Effect of vascular access construction on ventricular volumes and left ventricular remodeling
Assessed by doppler echocardiography
Measured: 2 years
Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function
Cognitive functions are assessed by psychic and autonomy scores
Measured: 2 years
Secondary outcomes (4)
Complications of vascular access
Described as %.Complications including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.
Measured: 2 years
Cost-effectiveness of different vascular access
Described as $.The cost including medical expenses and non-medical expenses.
Measured: 2 years
Hospitalization rate due to vascular access.
Measured: 2 years
Mortality due to vascular access
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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 Shanghai Changzheng 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital
- Responsible party
- Principal investigator, Changlin Mei, Shanghai Changzheng Hospital
- Investigators
- Changlin Mei, master, Principal investigator, Division of Nephrology, Shanghai ChangZheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272374
- Sponsor's protocol ID
- CZHKI-HDVA-004
- Acronym
- ACCESS-China
- Status last verified
- Oct 2014
- First submitted
- 23 Sep 2014
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China :a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02272374
- Acronym / sponsor ID
- ACCESS-China / CZHKI-HDVA-004
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis, Arteriovenous fistula, Tunneled cuffed catheter, Arteriovenous graft, Elderly, Very elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Oct 2014 (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 purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous graft) in the elderly and very elderly with end-stage renal disease in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| e-AVF group | Experimental | Procedure: AVF creation120 elderly with end stage renal disease will undergo AVF creation. |
| e-TCC group | Experimental | Procedure: TCC placement120 elderly with end stage renal disease will undergo TCC placement. |
| e-AVG group | Experimental | Procedure: AVG creation60 elderly with end stage renal disease will undergo AVG creation. |
| ve-AVF group | Experimental | Procedure: AVF creation80 very elderly with end stage renal disease will undergo AVF creation. |
| ve-TCC group | Experimental | Procedure: TCC placement80 very elderly with end stage renal disease will undergo TCC placement. |
| ve-AVG group | Experimental | Procedure: AVG creation40 very elderly with end stage renal disease will undergo AVG creation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- The elderly and very elderly with end stage renal disease.
- Estimated glomerular filtration rate (eGFR) <20ml/min*1.73m2
- All study subjects agree to participate in the study and provide written informed consent.
Key exclusion criteria (2 listed)
- Patients' life expectancy is less than 2 years.
- Mental illness that makes the patients unable to complete the trial.
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 creationAlso: Arteriovenous fistula creation | Procedure or surgery | e-AVF group, ve-AVF group |
| TCC placementAlso: Tunneled cuffed catheter placement | Procedure or surgery | e-TCC group, ve-TCC group |
| AVG creationAlso: Arteriovenous graft creation | Procedure or surgery | e-AVG group, ve-AVG group |
Primary outcome
The patency rate of vascular access
Time frame: 2 years
Including primary and secondary patency rate.Blood flow can be above 500 mL/min in a mature arteriovenous fistula by ultrasound scan and 4 times of body weight (Kg*4 mL/min) in a arteriovenous graft or tunneled cuffed catheter in dialysis practice.
Effect of vascular access construction on ventricular volumes and left ventricular remodeling
Time frame: 2 years
Assessed by doppler echocardiography
Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function
Time frame: 2 years
Cognitive functions are assessed by psychic and autonomy scores
4 secondary outcomes
Complications of vascular access
Time frame: 2 years
Cost-effectiveness of different vascular access
Time frame: 2 years
Hospitalization rate due to vascular access.
Time frame: 2 years
Mortality due to vascular access
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
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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.
Changlin Mei, master principal investigator
Division of Nephrology, Shanghai ChangZheng 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 AVF creation, TCC placement and AVG creation in people with End Stage Renal Disease, run by Shanghai Changzheng 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 3 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 22 Oct 2014. 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 Xiaohong Hu, master (+8615026520819, huxiaohong8305@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patency rate of vascular access (time frame: 2 years). The study lists 3 primary outcomes in all. 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 22 Oct 2014.