The Relationship Between the Flow of Arteriovenous Fistula and Cardiac Function in Haemodialysis Patients

Complication of Hemodialysis Clinical Trial

Official title:

Study of Access Flow ,Access Recirculation of Arteriovenous Fistula and the Relationship With Cardiac Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747966
• Other study ID #: SYSU-HD02
• Status: Completed
• Phase: N/A
• First received: May 21, 2015
• Last updated: April 25, 2016
• Start date: April 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

A prospective longitudinal surveillance for a period of 2 months. Sample - identify suitable Chronic Kidney Disease (CKD) patients who undergo HD with functioning AVF. Participants at various age range and both sexes are recruited to observe their access flow, access recirculation and cardiac function and assess their relationship.

Description:

All patients recruited who met the inclusion criteria were investigated access flow, access recirculation and cardiac function(including cardiac output,cardiac index,central blood volume,et al).Measurement time is the beginning of HD session (first 30min to 1 hr),Middle of HD session (optional),and the end of the HD session (1hr to 30 min prior to end of session). The follow-up duration is 6 months and 12 months.Repeat the assessment at the above time points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients undergo HD with native AVF

• AF of AVF between 300ml/min and 1800ml/min

Exclusion Criteria:

• Patients whose AVF developed Access Recirculation (AR) which cannot be resolved at the time of measurement

• Patients developed access or systemic infection during the study period

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Complication of Hemodialysis

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital, Sun Yet-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to access the chang of the fistula blood flow in HD patients using Ultrasound Dilution method		Change of the fistula blood flow from baseline to 6 months	No
Secondary	Changes of the Cardiac Index (CI) during the course of hemodialysis therapy		from baseline to 6 months	No
Secondary	Changes of the Oxygen delivery ( Adequacy of hemoglobin level to Epoetin) during the course of hemodialysis therapy		from baseline to 6 months	No