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Cohort Study on A Following-up System of Native Arteriovenous Fistulae

Primary Purpose

Arteriovenous Fistulae

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Assessment guiding surgery and puncture for AVF
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Fistulae focused on measuring hemodialysis, chronic renal failure, arteriovenous fistulae

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Maintenance hemodialysis patients using AVF;
  • Ages 18-70 years old;
  • Agreement with frequent following-up.

Exclusion Criteria:

  • Younger than 18 years or elder than 70 years;
  • Cachexia;
  • Acute renal failure;
  • Exceptive life time less than 6 months;
  • Pregnant or planning pregnant;
  • Waiting for renal transplantation or transferring to peritoneal dialysis.

Sites / Locations

  • Peking University International Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.

Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.

Outcomes

Primary Outcome Measures

Number of Participants With Fistula Failure
The AVF can not be used for hemodialysis treatment 3 months after surgery, which it is defined as Primary Failure of AVF. The primary failure of AVF is regarded as the primary outcome of the patients who were followed up. The ratio of primary failure will be compared between two groups.

Secondary Outcome Measures

Life Time of AVF
The life time of an available AVF since the AVF is functionable. The life time of an AVF is a period time from the AVF used for hemodialysis treatment at first time to the last time when the AVF can not be used for hemodialysis therapy,, whichever came first, assessed up to 48 months. Since the AVF will be punctured in every hemodialysis session, the function of AVF were detected during every treatment session (3 times per week).

Full Information

First Posted
August 17, 2016
Last Updated
June 11, 2019
Sponsor
Capital Medical University
Collaborators
Peking University International Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02880761
Brief Title
Cohort Study on A Following-up System of Native Arteriovenous Fistulae
Official Title
Cohort Study on A Following-up System of Native Arteriovenous Fistulae in Chinese Patients Treated by Maintenance Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
Collaborators
Peking University International Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A cohort including more than 100 maintenance hemodialysis patients will be followed up according to a certain Following-up System of Native Arteriovenous Fistulae (AVF) prospectively. The assessment results of the Following-up System of AVF help the physicians make decisions of AVF surgery and puncture methods. The results of this study would identify the effect of the system on survival of AVF. Other 100 hemodialysis patients from other centers will be treated by routine protocol and compared to the experiment goup.
Detailed Description
The Following-up System of AVF includes 3 stages. In the 1st stage, before AVF surgery operation, the contents of Following-up System of AVF include history, physical exam, ultrasonography detection. The assesment results will guide the methods of the AVF surgery operation. In the 2nd stage, before AVF puncture firstly and 3 months after AVF operation, the contents of Following-up System of AVF include physical exam and ultrasonography detection. The results will help the nurses and doctors make a decision of the method of AVF puncture. In the 3rd stage, during the following 2 years after AVF puncture successfully, the contents include physical exam and ultrasonography detection regularly. The adequacy of hemodialysis by using AVF will be assessed by urea clearance index (Kt/V). The data of patients in other hemodialysis centers will be recorded and compared to the patients in experiment group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistulae
Keywords
hemodialysis, chronic renal failure, arteriovenous fistulae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.
Intervention Type
Procedure
Intervention Name(s)
Assessment guiding surgery and puncture for AVF
Intervention Description
Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF
Primary Outcome Measure Information:
Title
Number of Participants With Fistula Failure
Description
The AVF can not be used for hemodialysis treatment 3 months after surgery, which it is defined as Primary Failure of AVF. The primary failure of AVF is regarded as the primary outcome of the patients who were followed up. The ratio of primary failure will be compared between two groups.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Life Time of AVF
Description
The life time of an available AVF since the AVF is functionable. The life time of an AVF is a period time from the AVF used for hemodialysis treatment at first time to the last time when the AVF can not be used for hemodialysis therapy,, whichever came first, assessed up to 48 months. Since the AVF will be punctured in every hemodialysis session, the function of AVF were detected during every treatment session (3 times per week).
Time Frame
Equal to or larger than 2 years
Other Pre-specified Outcome Measures:
Title
Mean Value of Urea Clearance Index During 24 Months
Description
As a parameter of hemodialysis adequacy, urea clearance index (Kt/V) will be detected very month. The Kt/V should be larger than 1.2 , which were regarded as being adequate in the hemodialysis session. This parameter will be tested every month and the mean value were be calculated according to the records during 24 months. Those who with Kt/V less than 1.2 for 3 times would be defined as the patient with unfunctional AVF. The values of Kt/V in unfunctional AVF patients would not be used in statistic analysis.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Maintenance hemodialysis patients using AVF; Ages 18-70 years old; Agreement with frequent following-up. Exclusion Criteria: Younger than 18 years or elder than 70 years; Cachexia; Acute renal failure; Exceptive life time less than 6 months; Pregnant or planning pregnant; Waiting for renal transplantation or transferring to peritoneal dialysis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongliang Zhang, Doctor
Organizational Affiliation
Peking University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University International Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102206
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Cohort Study on A Following-up System of Native Arteriovenous Fistulae

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