ANZCTR - Registration

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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]

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.

Condition category

Condition code

Renal and Urogenital

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]

Prevention

Intervention code [2]

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]

Urine pH (measured using a pH meter pen, Digitech)

Timepoint [1]

After commencement of therapy (at next bladder void)

Secondary outcome [1]

Serum creatinine (via blood analysis)

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

Studley Road, Heidelberg, Victoria 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Studley Road, Heidelberg, Victoria, 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Ms Phung To

Address

Pharmacy Department, Austin Health, Studley Road, Heidelberg, Victoria 3084

Country

Australia

Phone

+61 3 9496 5000

Fax

phung.to@austin.org.au

Contact person for public queries

Name

Ms Phung To

Address

C/-Pharmacy Department
Austin Health
Studley Road, Heidelberg, Victoria, 3084

Country

Australia

Phone

+61 3 9496 5291

Fax

phung.to@austin.org.au

Contact person for scientific queries

Name

Dr Peter Mount

Address

C/- Nephrology Department
Austin Health
Studley Road, Heidelberg, Victoria, 3084

Country

Australia

Phone

+61 3 9496 5000

Fax

peter.mount@austin.org.au

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.

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