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| Name | Class |
|---|---|
| Peking University International Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment guiding surgery and puncture for AVF | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Value of Urea Clearance Index During 24 Months | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongliang Zhang, Doctor | Peking University First Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University International Hospital | Beijing | Beijing Municipality | 102206 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 3 months after surgery |
|
2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute myocardial infarction | Cardiac disorders | Non-systematic Assessment | Newly happened acute myocardial infarction. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Continuous Quality Improvement Experts Congress of Changping District | Continuous Quality Improvement Experts Congress of Changping District | +861069006549 | 1069006789 | zhangdongliang@pkuih.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2016 | Jun 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D011677 | Punctures |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Equal to or larger than 2 years |
| 2 years |
| Protocol Violation |
|
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height(cm) | Mean | Standard Deviation | cm |
|
| Weight(Kg) | Mean | Standard Deviation | Kg |
|
| OG001 | 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. |
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | month | Equal to or larger than 2 years |
|
|
|
| Other Pre-specified | Mean Value of Urea Clearance Index During 24 Months | 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. | Posted | Mean | Standard Deviation | Kt/V | 2 years |
|
|
|
| 6 |
| 103 |
| 4 |
| 103 |
| 2 |
| 103 |
| EG001 | 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. | 8 | 106 | 6 | 106 | 1 | 106 |
|
| Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |