Cohort Study on A Following-up System of Native Arteriovenous Fistulae
11 juni 2019 uppdaterad av: Dongliang Zhang, MD, Capital Medical University
Cohort Study on A Following-up System of Native Arteriovenous Fistulae in Chinese Patients Treated by Maintenance Hemodialysis
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
209
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Beijing
-
Beijing, Beijing, Kina, 102206
- Peking University International Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Fistula Failure
Tidsram: 3 months after surgery
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Life Time of AVF
Tidsram: Equal to or larger than 2 years
|
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).
|
Equal to or larger than 2 years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Value of Urea Clearance Index During 24 Months
Tidsram: 2 years
|
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.
|
2 years
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Samarbetspartners och utredare
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Sponsor
Samarbetspartners
Utredare
- Studiestol: Dongliang Zhang, Doctor, Peking University Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2016
Primärt slutförande (Faktisk)
1 augusti 2018
Avslutad studie (Faktisk)
1 september 2018
Studieregistreringsdatum
Först inskickad
17 augusti 2016
Först inskickad som uppfyllde QC-kriterierna
23 augusti 2016
Första postat (Uppskatta)
26 augusti 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 augusti 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juni 2019
Senast verifierad
1 juni 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2016-019
Plan för individuella deltagardata (IPD)
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OBESLUTSAM
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