A pilot study to determine the effects of sodium bicarbonate on urinary pH in patients at risk of contrast induced nephropathy.

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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.

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