Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients With Renal Insufficiency (RI) Grade III Under Study Conducting Computed Tomography (CT)

Study Overview
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Brief Summary
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This study evaluates if oral hydratation is as effective as endovenous hydratation in the prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under study conducting contrasted computed tomography.

Official Title
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Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Other: Oral hydratation
* Drug: Bicarbonate endovenous hydratation
* Drug: Saline endovenous hydratation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes over 18 years Candidates for a study with computed tomography and intravenous contrast A glomerular filtration rate between 30 and 45 mL / min including both determinations They have signed the written informed consent after being informed of the objectives and the nature of the case or be unable to have the authorization or agreement of its Exclusion Criteria: refuse to participate in the study pregnancy or lactation Other risk factors for Contrast Induced Nephropathy: diabetes mellitus type I, have an age of 75 years or above, heart failure (defined by a scale New York Heart Association 3 or 4), hypotension (defined as systolic blood pressure <100), being treated with nephrotoxic medications. Any disease or a history that, in the investigator's opinion, could confound the results of the study or pose an additional risk to patient treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Oral hydratation<br> | Other: Oral hydratation<br>* 500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography<br>|
| Active Comparator: Endovenous hydratation<br> | Drug: Bicarbonate endovenous hydratation<br>* Intravenous hydration: sodium (1.6 molar) Bicarbonate 3 mL / kg / h starting one hour before the computed tomography and sodium bicarbonate (1/6 M) 1 mL / kg / h during the hour after computed tomography.<br>Drug: Saline endovenous hydratation<br>* If there is contraindication for administration of bicarbonate the pattern of intravenous hydration is performed with saline solution: 3 ml / kg / h for 1 hour before the procedure and normal saline 1 mL / kg / hour for hour after computed tomography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of contrast induced nephropathy | Contrast induced nephropathy defined as a creatinine increase> 0.5 mg / dl comparing the initial blood test to the blood test performed after 48-72 hours to the completion of the computed tomography | 48-72 hours after the completion of the computed tomography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for hemodialysis | Need for hemodialysis for one month after completion of the computed tomography, among patients who have undergone oral or intravenous hydration | 15 days | 
| Reversibility of contrast induced nephropathy | Defined as no increase in creatinine> 0.5 mg / dl compared to the initial analysis performed | 15 days | 
| Proportion of adverse events | Presence of adverse events, grade 3 adverse events and serious adverse events related to the investigational products during the study follow-up | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast-induced nephropathy, renal insufficiency, computed tomography