Cohort Study on A Following-up System of Native Arteriovenous Fistulae
11. juni 2019 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
209
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 102206
- Peking University International Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Ingen inngripen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Fistula Failure
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Life Time of AVF
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Value of Urea Clearance Index During 24 Months
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Dongliang Zhang, Doctor, Peking University Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2016
Primær fullføring (Faktiske)
1. august 2018
Studiet fullført (Faktiske)
1. september 2018
Datoer for studieregistrering
Først innsendt
17. august 2016
Først innsendt som oppfylte QC-kriteriene
23. august 2016
Først lagt ut (Anslag)
26. august 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. juni 2019
Sist bekreftet
1. juni 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2016-019
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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