- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02880761
Cohort Study on A Following-up System of Native Arteriovenous Fistulae
Cohort Study on A Following-up System of Native Arteriovenous Fistulae in Chinese Patients Treated by Maintenance Hemodialysis
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Beijing
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Beijing, Beijing, Cina, 102206
- Peking University International Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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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
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Participants With Fistula Failure
Lasso di tempo: 3 months after surgery
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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.
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3 months after surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Life Time of AVF
Lasso di tempo: Equal to or larger than 2 years
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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).
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Equal to or larger than 2 years
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Mean Value of Urea Clearance Index During 24 Months
Lasso di tempo: 2 years
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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.
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2 years
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Dongliang Zhang, Doctor, Peking University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2016-019
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Assessment guiding surgery and puncture for AVF
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