- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02747966
The Relationship Between the Flow of Arteriovenous Fistula and Cardiac Function in Haemodialysis Patients
April 25, 2016 updated by: Xue Qing Yu, Sun Yat-sen University
Study of Access Flow ,Access Recirculation of Arteriovenous Fistula and the Relationship With Cardiac Function
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- The 1st Affiliated Hospital, Sun Yet-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All eligible participants are recruited according the inclusion and exclusion criteria.Their basis data are documented and the central hemodynamic condition are assess cross-sectionally and longitudinally.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
to access the chang of the fistula blood flow in HD patients using Ultrasound Dilution method
Time Frame: Change of the fistula blood flow from baseline to 6 months
|
Change of the fistula blood flow from baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes of the Cardiac Index (CI) during the course of hemodialysis therapy
Time Frame: from baseline to 6 months
|
from baseline to 6 months
|
|
Changes of the Oxygen delivery ( Adequacy of hemoglobin level to Epoetin) during the course of hemodialysis therapy
Time Frame: from baseline to 6 months
|
from baseline to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xueqing Yu, MD, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
May 21, 2015
First Submitted That Met QC Criteria
April 21, 2016
First Posted (Estimate)
April 22, 2016
Study Record Updates
Last Update Posted (Estimate)
April 26, 2016
Last Update Submitted That Met QC Criteria
April 25, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSU-HD02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complication of Hemodialysis
-
Medical Centre LeeuwardenCompleted
-
Renal Research InstituteCompleted
-
Mashhad University of Medical SciencesUnknownComplication of HemodialysisIran, Islamic Republic of
-
Groene Hart ZiekenhuisArcher ResearchCompletedVascular Access Complication | Complication of HemodialysisBelgium, Netherlands
-
Alexandria UniversityCompletedHemodialysis ComplicationEgypt
-
National Taiwan University HospitalCompletedHemodialysis Complication | Hemodialysis-Induced SymptomTaiwan
-
Cairo UniversityNot yet recruitingHemodialysis ComplicationEgypt
-
Alexandria UniversityCompletedHemodialysis ComplicationEgypt
-
Eurofarma Laboratorios S.A.Completed
-
Universitaire Ziekenhuizen KU LeuvenNIPROCompletedHemodialysis ComplicationBelgium