Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000205336
Ethics application status
Approved
Date submitted
10/04/2008
Date registered
16/04/2008
Date last updated
16/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oral sodium bicarbonate to reduce contrast induced nephropathy
Scientific title
Oral sodium bicarbonate to reduce contrast induced nephropathy in the out-patient coronary angiogram population - a randomised, double blinded study in patients with renal impairment
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 3032 0
Renal impairment 3033 0
Diabetes mellitus 3034 0
Contrast induced nephropathy 3035 0
Condition category
Condition code
Cardiovascular 3185 3185 0 0
Coronary heart disease
Renal and Urogenital 3186 3186 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sodium bicarbonate capsules (840mg) - doses given day prior to coronary angiography and on the day of procedure. This is on top of routine pre-angiography intravenous hydration.
Intervention code [1] 2778 0
Treatment: Drugs
Comparator / control treatment
Control treatment - intravenous hydration prior to coronary angiography.
Control group
Active

Outcomes
Primary outcome [1] 4074 0
Incidence of contrast induced nephropathy in active and placebo groups
Timepoint [1] 4074 0
Day 2 and Day 7 renal function assessment from time of angiography
Secondary outcome [1] 6860 0
Assess the rate of contrast induced nephropathy in patients with diabetes mellitus and pre-morbid renal impairment.
Timepoint [1] 6860 0
Day 2 and Day 7 renal function assessment from time of angiography.

Eligibility
Key inclusion criteria
Estimated glomerular filtration rate < 60mL/min
Adults > 18years old
Able to provide informed consent
Awaiting elective coronary angiography
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
New York Heart Association III or IV
Acute myocardial infarction
Acute pulmonary oedema
Pregnancy
Renal replacement therapy
Medical kidney disease (multiple myeloma, acute nephritis)
Prior use of N-acetylcysteine or sodium bicarbonate or intravenous contrast agent in the preceding 4 weeks

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3310 0
Self funded/Unfunded
Name [1] 3310 0
Michael Mok
Country [1] 3310 0
Australia
Primary sponsor type
Other
Name
Michael Mok
Address
Cardiology Department
Geelong Hospital
Level 4 Kardinia House
Corner of Ryrie and Bellarine Street
Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 2942 0
None
Name [1] 2942 0
Address [1] 2942 0
Country [1] 2942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5273 0
Barwon Health Ethics and Research Committe
Ethics committee address [1] 5273 0
Geelong Hospital
Kitcheners House
Ryrie Street
Geelong VIC 3220
Ethics committee country [1] 5273 0
Australia
Date submitted for ethics approval [1] 5273 0
Approval date [1] 5273 0
29/03/2008
Ethics approval number [1] 5273 0
08/03

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28518 0
Address 28518 0
Country 28518 0
Phone 28518 0
Fax 28518 0
Email 28518 0
Contact person for public queries
Name 11675 0
Michael Mok
Address 11675 0
Cardiology Department
Geelong Hospital
Level 4 Kardinia House
Corner of Ryrie and Bellarine Street
Geelong VIC 3220
Country 11675 0
Australia
Phone 11675 0
+61 3 52267111
Fax 11675 0
Email 11675 0
[email protected]
Contact person for scientific queries
Name 2603 0
Michael Mok
Address 2603 0
Cardiology Department
Geelong Hospital
Level 4 Kardinia House
Corner of Ryrie and Bellarine Street
Geelong VIC 3220
Country 2603 0
Australia
Phone 2603 0
+61 3 52267111
Fax 2603 0
Email 2603 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
No additional documents have been identified.