Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

Conditions
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Acute Kidney Failure

Intervention / Treatment
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* Drug: Bicarbinate 150 mEq/L


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bicarbinate 150 mEq/L|75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast |  | 48 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in serum bicarbonate; change in serum potassium; change in serum creatinine |  | 48 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bicarbonate, nephropathy, contrast