Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000049279
Ethics application status
Approved
Date submitted
21/12/2008
Date registered
21/01/2009
Date last updated
21/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of markers of Oxidative stress, Myocardial structure and function, Inflammation and Vascular structure and function between Incident hemodialysis and peritoneal Dialysis patients (COMIVID) an Observational Study
Scientific title
Comparison of markers of Oxidative stress, Myocardial structure and function, Inflammation and Vascular structure and function between Incident hemodialysis and peritoneal Dialysis patients (COMIVID) an Observational Study
Secondary ID [1] 772 0
Nil
Universal Trial Number (UTN)
Trial acronym
COMIVID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 4151 0
Condition category
Condition code
Renal and Urogenital 4360 4360 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparison of vascular structure and function and measures of oxidative stress and inflammation in incident peritoneal dialysis versus hemodialysis over 12 months
vascular structure and function will be measured with pulse wave analysis and velocity, carotid intimal medial thickness, brachial forearm reactivity and oxidative stress measured with plasma F2 Isoprostanes and inflammation with plasma pentraxin-3.
Intervention code [1] 3869 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5234 0
Inflammatory measure pentraxin-3 (blood analysis)
Timepoint [1] 5234 0
Baseline and 6 and 12 months after starting peritoneal or hemodialysis
Secondary outcome [1] 8820 0
oxidative stress F2 Isoprostanes (blood measure)
Timepoint [1] 8820 0
Baseline and 6 and 12 months after starting hemodialysis or peritoneal dialysis
Secondary outcome [2] 8932 0
Blood oxidative stress
Timepoint [2] 8932 0
Baseline and 6 and 12 months after starting dialysis
Secondary outcome [3] 8942 0
Pulsewave analysis (Augmentation Index)
Timepoint [3] 8942 0
Baseline and at 6 and 12 months after starting dialysis
Secondary outcome [4] 8943 0
Pulsewave velocity
Timepoint [4] 8943 0
Baseline and at 6 and 12 months after starting dialysis

Eligibility
Key inclusion criteria
Age >18 yrs and < 85 years
End stage kidney disease eGFR< 30 ml/min/1.73m2
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
failure to gain informed consent
intolerance of glyceryl trinitrate

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1351 0
7250

Funding & Sponsors
Funding source category [1] 4322 0
Charities/Societies/Foundations
Name [1] 4322 0
Clifford Craig Medical Research Trust
Country [1] 4322 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Baxter Healthcare
Address
One Baxter Drive
Old Toongabbie
NSW, 2146
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 3953 0
Hospital
Name [1] 3953 0
Launceston General Hospital
Address [1] 3953 0
Charles Street
Launceston
Tasmania, 7250
Country [1] 3953 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6444 0
Tasmanian Statewide HREC
Ethics committee address [1] 6444 0
Executive Officer, Human Research Ethics
Office of Research Services
University of Tasmania
Private Bag 01
HOBART TAS 7001
Ethics committee country [1] 6444 0
Australia
Date submitted for ethics approval [1] 6444 0
Approval date [1] 6444 0
01/01/2007
Ethics approval number [1] 6444 0
H0009275

Summary
Brief summary
Cardiovascular disease is very common in patients who require dialysis treatment for kidney failure. There are two main types of dialysis treatment available for patients with kidney failure. Firstly there is peritoneal dialysis where fluids are run into and out of a soft plastic tube inserted into the patients’ abdomen with a minor surgical procedure. Toxins are removed as they diffuse across the membrane in the abdomen and are flushed out in the fluid. The second type is haemodialysis where toxins are removed from the blood stream as the blood is circulated through a filter outside the body.
There may be differing effects on the circulation and elements in the blood stream from these two quite different treatments. The aim of this research study is to see which treatment has the best effect on the heart and blood vessels and substances in the blood stream that indicate the degree of stress and inflammation present in the body. The heart and blood vessels will be assessed by a variety of probes outside the body that measure their “stiffness”, thickness and ability to contract and relax. We are aiming to find out whether one or other form of dialysis may be more beneficial over the first year by assessing the heart and blood vessels and substances in the blood. This may lead to recommendations for the initial form of dialysis treatment used.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 35056 0
Address 35056 0
Country 35056 0
Phone 35056 0
Fax 35056 0
Email 35056 0
Contact person for public queries
Name 12403 0
Professor Robert Fassett
Address 12403 0
Renal Medicine
Level 9 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Brisbane Queensland 4029
Country 12403 0
Australia
Phone 12403 0
0419399571
Fax 12403 0
Email 12403 0
[email protected]
Contact person for scientific queries
Name 3331 0
Associate Professor Jeff Coombes
Address 3331 0
Human Movement Studies
The University of Queensland
Country 3331 0
Australia
Phone 3331 0
0417166358
Fax 3331 0
Email 3331 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIComparison of markers of oxidative stress, inflammation and arterial stiffness between incident hemodialysis and peritoneal dialysis patients – an observational study2009https://doi.org/10.1186/1471-2369-10-8
N.B. These documents automatically identified may not have been verified by the study sponsor.