Trial Outcomes & Findings for Cohort Study on A Following-up System of Native Arteriovenous Fistulae (NCT NCT02880761)
NCT ID: NCT02880761
Last Updated: 2019-08-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
209 participants
Primary outcome timeframe
3 months after surgery
Results posted on
2019-08-02
Participant Flow
Participant milestones
| Measure |
Intervention
Patients with native arterovenous fistula (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.
Assessment guiding surgery and puncture for AVF: 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
|
Control
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.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
106
|
|
Overall Study
COMPLETED
|
87
|
85
|
|
Overall Study
NOT COMPLETED
|
16
|
21
|
Reasons for withdrawal
| Measure |
Intervention
Patients with native arterovenous fistula (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.
Assessment guiding surgery and puncture for AVF: 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
|
Control
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.
|
|---|---|---|
|
Overall Study
Death
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
Protocol Violation
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Cohort Study on A Following-up System of Native Arteriovenous Fistulae
Baseline characteristics by cohort
| Measure |
Intervention
n=87 Participants
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.
Assessment guiding surgery and puncture for AVF: 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
|
Control
n=85 Participants
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.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 year
STANDARD_DEVIATION 11.9 • n=99 Participants
|
55.3 year
STANDARD_DEVIATION 12.1 • n=107 Participants
|
55.3 year
STANDARD_DEVIATION 12.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Han
|
87 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Height(cm)
|
167.3 cm
STANDARD_DEVIATION 7.7 • n=99 Participants
|
167.4 cm
STANDARD_DEVIATION 7.9 • n=107 Participants
|
167.3 cm
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Weight(Kg)
|
67.0 Kg
STANDARD_DEVIATION 12.5 • n=99 Participants
|
66.6 Kg
STANDARD_DEVIATION 10.7 • n=107 Participants
|
66.8 Kg
STANDARD_DEVIATION 11.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months after surgeryThe 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.
Outcome measures
| Measure |
Intervention
n=87 Participants
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.
Assessment guiding surgery and puncture for AVF: 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
|
Control
n=85 Participants
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.
|
|---|---|---|
|
Number of Participants With Fistula Failure
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Equal to or larger than 2 yearsThe 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).
Outcome measures
| Measure |
Intervention
n=87 Participants
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.
Assessment guiding surgery and puncture for AVF: 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
|
Control
n=85 Participants
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.
|
|---|---|---|
|
Life Time of AVF
|
30.5 month
Standard Deviation 21.6
|
26.8 month
Standard Deviation 19.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsAs 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.
Outcome measures
| Measure |
Intervention
n=87 Participants
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.
Assessment guiding surgery and puncture for AVF: 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
|
Control
n=85 Participants
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.
|
|---|---|---|
|
Mean Value of Urea Clearance Index During 24 Months
|
1.31 Kt/V
Standard Deviation .28
|
1.29 Kt/V
Standard Deviation .27
|
Adverse Events
Intervention
Serious events: 4 serious events
Other events: 2 other events
Deaths: 6 deaths
Control
Serious events: 6 serious events
Other events: 1 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Intervention
n=103 participants at risk
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.
Assessment guiding surgery and puncture for AVF: 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
|
Control
n=106 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
acute myocardial infarction
|
1.9%
2/103 • Number of events 2 • 2 years.
|
4.7%
5/106 • Number of events 5 • 2 years.
|
|
Cardiac disorders
Heart Failure
|
1.9%
2/103 • Number of events 2 • 2 years.
|
2.8%
3/106 • Number of events 3 • 2 years.
|
Other adverse events
| Measure |
Intervention
n=103 participants at risk
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.
Assessment guiding surgery and puncture for AVF: 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
|
Control
n=106 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.9%
2/103 • Number of events 2 • 2 years.
|
0.94%
1/106 • Number of events 1 • 2 years.
|
Additional Information
Director of Continuous Quality Improvement Experts Congress of Changping District
Continuous Quality Improvement Experts Congress of Changping District
Phone: +861069006549
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60