Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Study Overview
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Brief Summary
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Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. The investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, >18 years old, with a GFR <60 and >30 ml/min/1,73m2 by MDRD formula and/or diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during and 6 hours before the injection. The primary end point will be the rise of 25% or more in creatinine or dialysis needed.

Official Title
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Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Conditions
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Radiographic Contrast Agent Nephropathy

Intervention / Treatment
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* Drug: sodium bicarbonate
* Drug: NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years old cancer diagnosis GFR < 60 and > 30 ml/min/1,73m2 by MDRD formula or diabetic CT with contrast Exclusion Criteria: dialysis needed uncontrolled hypertension changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure recent exposure to radiographic contrast agents (within previous two days of the study) administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sodium bicarbonate<br>Solution 154 mEq/L of sodium bicarbonate | Drug: sodium bicarbonate<br>* IV 154 mEq/L sodium bicarbonate. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.<br>|
| Active Comparator: Sodium chloride<br>Solution of 154 mEq/L of NaCl | Drug: NaCl<br>* IV 154 mEq/L solution of NaCl 0.9%. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.<br>|

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 2 day after administration of contrast or dialysis needed |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in serum bicarbonate change in serum potassium change in serum glucose change in serum creatinine change in estimated glomerular filtration rate incidence of contrast induced nephropathy comparison of cholesterol level |  | 2 days | 

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