- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00641875
The Effect of Nocturnal Haemodialysis on Arterial Stiffness
April 23, 2015 updated by: Melbourne Health
Arterial stiffness refers to the accumulation of extracellular deposits of matrix and calcium which reduce blood vessel compliance.
Although there is growing evidence that increased arterial stiffness is associated with chronic kidney disease (CKD), its pathogenesis is unclear.
Pulse wave velocity (PWV) and augmentation index (AIx) provide tools for estimating arterial stiffness, and therefore predicting cardiovascular morbidity and mortality.
The aims of the study are: (1) compare the effects of nocturnal and conventional haemodialysis on arterial stiffness, and (2) examine the relationship between arterial stiffness and clinical and biochemical parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
30
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All participants are adult patients who are receiving maintenance dialysis at the North West Dialysis Service.
Consecutive patients enrolled in the Nocturnal Haemodialysis program are invited to participate in the study
Description
Inclusion Criteria:
- adult dialysis patients
- able to perform home nocturnal haemodialysis
Exclusion Criteria:
- age < 18 and > 80 years
- any patient who is anticipating a live renal transplantation in forthcoming 12 months
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 purpose of this study is to evaluate the arterial stiffness in subjects who have undergone 12 months nocturnal haemodialysis.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To examine the relationship between arterial stiffness and clinical and biochemical parameters
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Lian, FRACP, MBBS, Department of Nephrology, Melbourne Health
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
December 1, 2005
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
March 17, 2008
First Submitted That Met QC Criteria
March 21, 2008
First Posted (Estimate)
March 24, 2008
Study Record Updates
Last Update Posted (Estimate)
April 27, 2015
Last Update Submitted That Met QC Criteria
April 23, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004.050
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.