prevention of contrast induced nephropathy with sodium bicarbonate

Conditions: Acute Kidney Failure

Summary: deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures. the purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition. we will perform a randomized clinical trial following a modification of a previously published protocol (merten et al.jama 2004;291(19):2328-34). patients will be randomly assigned to one of two groups of treatment. group a will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. group b will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.

we will perform a randomized clinical trial following a modification of a previously published protocol (merten et al.jama 2004;291(19):2328-34). patients will be randomly assigned to one of two groups of treatment. group a will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. group b will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure. phase 2/3 study study type: interventional study design: prevention, randomized, open label, active control, parallel assignment, efficacy study. subjects: consecutive samples of all inpatients who meet the inclusion criteria primary outcomes: development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast. secondary outcomes: change in serum bicarbonate; change in serum potassium; change in serum creatinine. expected total enrollment: 212 allocation assignment: patients who meet inclusion criteria and agree to participate in the study will be assigned by a random number table to saline or bicarbonate, using closed envelopes and stratifying according to history of diabetes and type of procedure (cardiac catheterism or others). condition: contrast induced nephropathy intervention: 75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of d5w gender: both age: 18+ years of age recruitment status: participants are currently being recruited facility location: universidad de antioquia, internal medicine department; hospital universitario san vicente de paul. medellin, colombia.

Eligibility criteria:
inclusion criteria: * 18+ years of age * inpatient at hospital universitario san vicente de paúl scheduled to undergo diagnostic ct scan using contrast or angiography and either * serum creatinine 1.2 mg/dl or more, or * type 2 diabetes mellitus exclusion criteria: * current clinical diagnosis of exacerbated congestive heart failure * exposure to contrast 30 days prior to study * allergy to contrast dye * chronic renal disease with dialysis therapy * acute renal failure with dialytic urgency * urgency procedure needed * systolic blood pressure \< 90 or vasopressor support * no authorization by patient or physician in charge * serum potassium \< 3 meq/l * ejection fraction \< 35% by previous echocardiography * acute pulmonary edema in previous 48 hours

Keywords: bicarbonate nephropathy contrast