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)

NCT ID: NCT02872155

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-04
• Study Completion Date: 2019-07-15

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.

Conditions

Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Oral hydratation

Group Type: EXPERIMENTAL

Oral hydratation

Intervention Type: OTHER

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

Endovenous hydratation

Group Type: ACTIVE_COMPARATOR

Bicarbonate endovenous hydratation

Intervention Type: DRUG

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 hydratation

Intervention Type: DRUG

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.

Interventions

Oral hydratation

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

Intervention Type: OTHER

Bicarbonate endovenous hydratation

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.

Intervention Type: DRUG

Saline endovenous hydratation

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: collaborator

David Garcia Cinca

OTHER

Sponsor Role: lead

Responsible Party

David Garcia Cinca

Clinical Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

NICIR

Identifier Type: -

Identifier Source: org_study_id