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)

David Garcia Cinca264 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

264

Conditions

Renal Insufficiency

Interventions

Oral hydratationOTHER

500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography

Bicarbonate endovenous hydratationDRUG

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.

Saline endovenous hydratationDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

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

Time frame: 48-72 hours after the completion of the computed tomography

Secondary Outcomes

Need for hemodialysis

Need for hemodialysis for one month after completion of the computed tomography, among patients who have undergone oral or intravenous hydration

Time frame: 15 days

Reversibility of contrast induced nephropathy

Defined as no increase in creatinine\> 0.5 mg / dl compared to the initial analysis performed

Time frame: 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

Time frame: 15 days

Data from ClinicalTrials.gov

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