Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether sodium bicarbonate is effective in the prevention of sodium-induced nephropathy

Detailed Description
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The use of contrast media is more frequent as new diagnostic and therapeutic procedures are developed. As a consequence, the occurrence of acute renal failure (ARF), also known as contrast-induced nephropathy, is more frequently seen after the realization of these procedures, representing about 10% of all in-hospital ARF. The importance of preventing this complication is related with its strong association with higher morbidity and mortality rates in patients who present it. A number of drugs and interventions have been studied for preventing contrast-induced nephropathy, including intravenous hydration with normal and hypotonic saline solutions, oral hydration, mannitol, diuretics, dopamine and its antagonists (fenoldopam), calcium antagonists, theophylline, N-acetylcysteine, natriuretic atrial peptide and hemodialysis after or during contrast media administration. There is only one study in humans that demonstrates the utility of the sodium bicarbonate to prevent the contrast-induced nephropathy, showing a reduction in the incidence of this complication of about 13.6%. Although this result could seem convincing, its relevance has been questioned because the definition used by the authors as contrast-induced nephropathy was an increase of 25% from basal creatinine. Although when compared, the absolute differences between basal and after-procedure creatinines were not statistically significative, the sample size was small and the participants were low-risk patients to develop contrast-induced nephropathy. It is also important to note that the control group was hydrated with a dextrose 5% solution with 154 mEq of NaCl, although today's most accepted prevention therapy is intravenous hydration with normal saline solution. Comparison: Hydration previously, during and afterwards contrast media administration with normal saline solution (0.9%), compared to hydration previous, during and afterwards contrast media administration with a solution made of normal saline and sodium bicarbonate.

Official Title
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Clinical Controlled Trial to Determinate the Role of Sodium Bicarbonate in the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing to Diagnostic Coronariography and/or Percutaneous Coronary Intervention

Conditions
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Acute Kidney Failure

Intervention / Treatment
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* Drug: Sodium bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old Indication for coronariography and/or percutaneous coronary intervention Voluntary written consent for the realization of coronariography and/or percutaneous intervention and for the participation in this clinical trial A MEHRAN contrast-induced nephropathy score of six or more Exclusion Criteria: Patients with chronic kidney failure requiring any kind of dialysis Patients unable to complete follow-up Multiple myeloma Exposure to contrast 48 hours prior to study Pregnancy Patients unable to give consent Already receiving sodium bicarbonate solutions Receiving contrast media other than non-ionic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


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 |
| --- | --- | --- |
| Contrast-induced nephropathy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodialysis |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney failure, Contrast-induced nephropathy, Non-ionic contrast media, Ionic contrast media, Iopamidol, Percutaneous coronary intervention, Coronariography