Kidney Failure, Acute Clinical Trial
Official title:
Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol)
Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.
A decline in kidney function after contrast is associated with prolonged hospital stay,
adverse cardiac events, and higher mortality both in hospital and in the long term.
Deliberate administration of fluids is recommended to reduce the risk of contrast
nephropathy. However, data to support specific recommendations are lacking and the optimal
fluid regimen remains unclear.
It has been hypothesized that alkalinization of tubular fluid might be beneficial by
reducing pH dependent free radical levels. A recent trial found a lower frequency of
creatinine rise > 25% within two days of contrast with a 7 hour infusion of isotonic sodium
bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be
proven that bicarbonate is superior as this trial has a number of methodological flaws.
Comparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the
same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1
ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2
ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of
fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality
contrast in the minimal dose needed to complete the required imaging.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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