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

David Garcia Cinca1 site in 1 country264 target enrollmentJuly 4, 2017

ConditionsRenal Insufficiency

InterventionsOral hydratation Bicarbonate endovenous hydratation Saline endovenous hydratation

DrugsBicarbonate endovenous hydratation Saline endovenous hydratation

Overview

Phase: Phase 3
Intervention: Oral hydratation
Conditions: Renal Insufficiency
Sponsor: David Garcia Cinca
Enrollment: 264
Locations: 1
Primary Endpoint: Proportion of contrast induced nephropathy
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 4, 2017

End Date

July 15, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

David Garcia Cinca

Responsible Party

Sponsor Investigator

Principal Investigator

David Garcia Cinca

Clinical Research Manager

Hospital Clinic of Barcelona

Eligibility Criteria

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.

Arms & Interventions

Oral hydratation

Intervention: Oral hydratation

Endovenous hydratation

Intervention: Bicarbonate endovenous hydratation

Endovenous hydratation

Intervention: Saline endovenous hydratation

Outcomes

Primary Outcomes

Proportion of contrast induced nephropathy

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

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