The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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
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

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

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

Study design
Purpose of the study
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
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237226 0
Name [1] 237226 0
Austin Health
Address [1] 237226 0
Studley Road, Heidelberg, Victoria 3084
Country [1] 237226 0
Primary sponsor type
Austin Health
Studley Road, Heidelberg, Victoria, 3084
Secondary sponsor category [1] 236717 0
Name [1] 236717 0
Address [1] 236717 0
Country [1] 236717 0

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

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

Principal investigator
Name 29812 0
Ms Phung To
Address 29812 0
Pharmacy Department, Austin Health, Studley Road, Heidelberg, Victoria 3084
Country 29812 0
Phone 29812 0
+61 3 9496 5000
Fax 29812 0
Email 29812 0
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
Phone 13059 0
+61 3 9496 5291
Fax 13059 0
Email 13059 0
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
Phone 3987 0
+61 3 9496 5000
Fax 3987 0
Email 3987 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary