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)

Phase 3

Completed

• Conditions: Renal Insufficiency
• Interventions: Other: Oral hydratation; Drug: Bicarbonate endovenous hydratation; Drug: Saline endovenous hydratation

• Registration Number: NCT02872155
• Lead Sponsor: David Garcia Cinca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Study Start: 2017-07-04
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral hydratation	Oral hydratation	-
Endovenous hydratation	Bicarbonate endovenous hydratation	-
Endovenous hydratation	Saline endovenous hydratation	-

Primary Outcome Measures

Name	Time	Method
Proportion of contrast induced nephropathy	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain