Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Study Overview
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Brief Summary
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Contrast nephropathy (CN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity/mortality, and cost. In addition, these patients may require temporary or permanent hemodialysis which, in turn, is associated with further morbidity, mortality, and cost. CN has been reported to account for 10% of hospital acquired renal failure. In recent years, studies have investigated preventive therapies with mixed results. Fenoldopam was found to be ineffective in a large randomized trial. Dopamine has been shown to be ineffective as a preventive strategy. Hemofiltration has been shown to be beneficial (New England Journal of Medicine [NEJM] 2003) but is costly and not practical. Mucomyst has shown mixed results. The single strategy which most would agree as being beneficial remains hydration, most commonly with intravenous 0.9% normal saline. Most recently, sodium bicarbonate has been shown to be beneficial in a small randomized trial (n=119). It is clear that the most cost effective strategies for treatment of CN should be aimed at prevention. The general question is: Is a sodium bicarbonate solution more efficacious in preventing contrast nephropathy compared to normal saline? The general hypothesis is that sodium bicarbonate will be more efficacious.

Official Title
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A Randomized Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Conditions
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Contrast Induced Nephropathy, Kidney Diseases

Intervention / Treatment
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* Drug: Sodium bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GFR < 60 mL/min/1.73m2. GFR will be adjusted by a correction factor as reported by our laboratory for patients self identifying as black. > 18 years and have at least one of the following risk factors for contrast nephropathy: diabetes (type 2), congestive heart failure, hypertension (> 140/90), or age > 75. Both inpatients and outpatients will be offered enrollment. Exclusion Criteria: Patients unable to give consent Already receiving sodium bicarbonate solution Undergoing emergency cardiac catheterization Receiving a contrast agent other than Oxilan On hemodialysis Recent exposure to contrast within 2 days Pulmonary edema Active congestive heart failure Severe valvular abnormality Recent significant change in kidney function (> 15% over 2d) One kidney Kidney transplant status

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sodium bicarbonate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of contrast induced nephropathy, defined by a decrease in glomerular filtration rate (GFR) by 25% or more |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in serum creatinine |  |  | 
| difference in hospital duration between groups |  |  | 
| need for hemodialysis |  |  | 
| 30 day mortality |  |  | 
| difference of baseline to lowest GFR and highest creatinine between groups |  |  | 
| difference in GFR and creatinine from baseline and 2-8 weeks later |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast induced nephropathy, sodium bicarbonate, cardiac catheterization