Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000285257
Ethics application status
Approved
Date submitted
25/04/2009
Date registered
18/05/2009
Date last updated
18/05/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
An assessment of arterial stiffness, oxidative stress and inflammation in acute kidney injury
Scientific title
An assessment of arterial stiffness, oxidative stress and inflammation in acute kidney injury
Secondary ID [1] 848 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney injury 4662 0
Condition category
Condition code
Renal and Urogenital 4969 4969 0 0
Kidney disease
Cardiovascular 237053 237053 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Arterial stiffness will be measured with pulse wave velocity, augmentation index together with oxidative stress (F2 isoprostanes) and inflammation(pentraxin-3). These will be measured on presentation with acute kidney injury and then at six and 12 months after
Intervention code [1] 4428 0
Not applicable
Comparator / control treatment
Measures of arterial stiffness (aortic pulse wave velocity m/sec) will be compared with age and gender matched controls recruited from the general community
Control group
Historical

Outcomes
Primary outcome [1] 5820 0
Aortic stiffness will be measured with aortic pulse wave velocity in m/sec measured with a Sphygmocor device
Timepoint [1] 5820 0
Baseline and 6 and 12 months after the onset of the acute kidney injury
Secondary outcome [1] 241820 0
oxidative stress measured with F2 isoprostanes (blood measure)
Timepoint [1] 241820 0
Baseline and 6 and 12 months after the onset of the acute kidney injury
Secondary outcome [2] 241821 0
Inflammation measured with pentraxin-3 (blood measure)
Timepoint [2] 241821 0
Baseline and 6 and 12 months after the onset of the acute kidney injury

Eligibility
Key inclusion criteria
Creatinine >133 umol/l or urea > 14.3 mmol/l or oliguria with urine output < 410 ml/day
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Already receiving dialysis or hemofiltration
Receiving ionotropic agents

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
15/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4850 0
Charities/Societies/Foundations
Name [1] 4850 0
Royal Brisbane and Women's Hospital Research Foundation
Country [1] 4850 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Royal Brisbane and Women's Hospital
Butterfield Street
Brisbane QLD 4029
Country
Australia
Secondary sponsor category [1] 4386 0
University
Name [1] 4386 0
The University of Queensland
Address [1] 4386 0
School of Human Movement Studies
St Lucia
Brisbane
QLD 4000
Country [1] 4386 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6907 0
Royal Brisbane and Women's Hospital Human Research and Ethics Committee (HREC)
Ethics committee address [1] 6907 0
Royal Brisbane and Women's Hospital
Butterfield Street
Brisbane QLD 4029
Ethics committee country [1] 6907 0
Australia
Date submitted for ethics approval [1] 6907 0
20/02/2009
Approval date [1] 6907 0
23/04/2009
Ethics approval number [1] 6907 0
HREC/09/QRBW/64

Summary
Brief summary
Vascular disease, characterised by premature atherosclerosis and large artery stiffness, is a feature of advanced chronic kidney disease (CKD) [1, 2]. Central pulse pressure, augmentation index (AIx) and aortic pulse wave velocity (PWV) are all predictors of morbidity and mortality in patients with CKD [1, 3, 4]. Large artery stiffness may also be related to the progression of CKD. The mechanisms and time frames for the development of arterial stiffness are unclear but may include traditional cardiovascular risk factors such as dyslipidemia and hypertension as well as non-traditional risk factors such as oxidative stress and inflammation. Moreover, to our knowledge no studies have assessed the relationship between arterial stiffness in the uraemic environment of acute kidney injury. Measuring arterial stiffness in this setting would enable us to determine whether changes in arterial stiffness occur due to the biochemical changes associated with acute kidney injury without the interference of factors that exist in chronic kidney disease. This may in turn help to understand the potential for reversibility of uremic biochemical effects on arterial stiffness.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 29533 0
Address 29533 0
Country 29533 0
Phone 29533 0
Fax 29533 0
Email 29533 0
Contact person for public queries
Name 12780 0
Professor Robert Fassett
Address 12780 0
Renal Medicine
Level 9 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street
Brisbane QLD 4029
Country 12780 0
Australia
Phone 12780 0
+61419399571
Fax 12780 0
Email 12780 0
rfassett@mac.com
Contact person for scientific queries
Name 3708 0
Professor Robert Fassett
Address 3708 0
Renal Medicine
Level 9 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street
Brisbane QLD 4029
Country 3708 0
Australia
Phone 3708 0
+61419399571
Fax 3708 0
Email 3708 0
rfassett@mac.com

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
EmbaseAssessment of arterial stiffness, oxidative stress and inflammation in acute kidney injury.2009https://dx.doi.org/10.1186/1471-2369-10-15
N.B. These documents automatically identified may not have been verified by the study sponsor.