Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000550202
Ethics application status
Approved
Date submitted
29/06/2009
Date registered
7/07/2009
Date last updated
2/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to determine the effects of sodium bicarbonate on urinary pH in patients at risk of contrast induced nephropathy.
Scientific title
A pilot study to determine the effects of sodium bicarbonate on urinary pH in patients at risk of contrast induced nephropathy.
Secondary ID [1] 907 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients at risk of contrast induced nephropathy. 237114 0
Condition category
Condition code
Renal and Urogenital 237442 237442 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sodium bicarbonate (840 mg, 10 mmols) oral capsules - 4 capsules initially followed by 3 capsules 1 hour later then 3 capsules every 2 hourly for a total of 6 hours. (Total 16 capsules)
Intervention code [1] 236836 0
Prevention
Intervention code [2] 236837 0
Treatment: Drugs
Comparator / control treatment
Sodium bicarbonate intravenous - 150 mmol/L (in 5% glucose 1 L bag) at 3 mL/kg/hrfor 1 hr prior, then 1 mL/kg/hr during and for 6 hrs after contrast procedure. Approximate duration of contrast procedure is 30 minutes to 1.5 hours depending on procedure performed.
Control group
Active

Outcomes
Primary outcome [1] 238244 0
Urine pH (measured using a pH meter pen, Digitech)
Timepoint [1] 238244 0
After commencement of therapy (at next bladder void)
Secondary outcome [1] 244581 0
Serum creatinine (via blood analysis)
Timepoint [1] 244581 0
Within 48 hours of contrast administration

Eligibility
Key inclusion criteria
Patients at risk of contrast induced nephropathy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide written consent.
Patient requires an urgent coronary angiogram.
Pregnancy.
Breastfeeding.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/07/2009
Actual
3/09/2009
Date of last participant enrolment
Anticipated
1/12/2010
Actual
1/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237226 0
Hospital
Name [1] 237226 0
Austin Health
Country [1] 237226 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Studley Road, Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 236717 0
None
Name [1] 236717 0
Address [1] 236717 0
Country [1] 236717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239327 0
Austin Health Ethics Committee
Ethics committee address [1] 239327 0
Ethics committee country [1] 239327 0
Australia
Date submitted for ethics approval [1] 239327 0
Approval date [1] 239327 0
Ethics approval number [1] 239327 0

Summary
Brief summary
The hypothesis for this study is that orally administered sodium bicarbonate has a similar effect on urine pH and serum bicarbonate as intravenously administered sodium bicarbonate.

Contrast-induced nephropathy is a condition in which kidney damage can occur as a result of the use of contrast (dyes) given to patients during some radiology scans of the body. A drug called sodium bicarbonate is currently given intravenously (through the vein) to prevent contrast-induced nephropathy in those at high-risk. There are some disadvantages associated with the intravenous administration of the drug. For example, patients require insertion of an intravenous line specifically for the drug administration and need to be admitted to the hospital early in order for the line to be inserted and for drug administration to begin. Most importantly, patients will have to wait for at least 6 hours after they receive contrast for the sodium bicarbonate administration to be completed. The use of an oral form of the drug will overcome these issues. Sodium bicarbonate is available in an oral/capsule form; however, there is currently no information available to indicate that it is as effective as the intravenous form for the prevention of contrast-induced nephropathy.

Sodium bicarbonate works to prevent contrast induced nephropathy by making the urine alkaline. The intravenous version of the drug is approved for urinary alkalinisation in Australia but the oral form is not even though it works the same way and is used world-wide for alkalinisation of the urine. The Australian approved indication for oral sodium bicarbonate is for a condition called metabolic alkalosis. For this condition the oral sodium bicarbonate works by alkalinising the urine.

The purpose of this study is to see whether the effects of intravenous sodium bicarbonate on patients who are given this drug as part of their routine care is similar to that in patients who are given the oral version of the drug. In particular, patients’ blood test results and urine acidity/alkalinity (pH) will be studied. The results obtained will be used to decide whether it might be possible to do a larger study directly comparing the effectiveness of oral sodium bicarbonate with intravenous sodium bicarbonate to prevent contrast induced nephropathy in patients at risk.

There are 2 parts to the study. In part 1, participants will attend Austin Health for their coronary angiogram or stent procedure as normal. The only requirements beyond routine care are two extra urine samples and an extra blood test. In the second part of the study participants (from part 1) will be asked to return to hospital 2 to 3 weeks after their procedure, take some sodium bicarbonate capsules, and provide two urine samples and two blood samples for testing. The urine samples and blood samples will be compared.
Trial website
Trial related presentations / publications
To TP, Chahadi F, Freeman M, Pan M, Farouque O, Mount P. Urinary alkalinisation with oral sodium bicarbonate for patients at risk of contrast-induced nephropathy. J Pharm Prac Res 2012; 42: 118-20.
Public notes

Contacts
Principal investigator
Name 29812 0
Ms Phung To
Address 29812 0
Pharmacy Department, Austin Health, Studley Road, Heidelberg, Victoria 3084
Country 29812 0
Australia
Phone 29812 0
+61 3 9496 5000
Fax 29812 0
Email 29812 0
[email protected]
Contact person for public queries
Name 13059 0
Ms Ms Phung To
Address 13059 0
C/-Pharmacy Department
Austin Health
Studley Road, Heidelberg, Victoria, 3084
Country 13059 0
Australia
Phone 13059 0
+61 3 9496 5291
Fax 13059 0
Email 13059 0
[email protected]
Contact person for scientific queries
Name 3987 0
Dr Dr Peter Mount
Address 3987 0
C/- Nephrology Department
Austin Health
Studley Road, Heidelberg, Victoria, 3084
Country 3987 0
Australia
Phone 3987 0
+61 3 9496 5000
Fax 3987 0
Email 3987 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.