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)

NCT02872155 | Completed Phase 3

• 1 other identifier: NICIR
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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

Keywords

contrast-induced nephropathy; renal insufficiency; computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Need for hemodialysis

  15 days

• Reversibility of contrast induced nephropathy

  15 days

• Proportion of adverse events

  15 days

Study Arms (2)

Oral hydratation

EXPERIMENTAL

Other: Oral hydratation

Endovenous hydratation

ACTIVE COMPARATOR

Drug: Bicarbonate endovenous hydratation; Drug: Saline endovenous hydratation

Interventions

Oral hydratation OTHER

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

Oral hydratation

Bicarbonate endovenous hydratation 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.

Endovenous hydratation

Saline endovenous hydratation 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.

Endovenous hydratation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Garcia Cinca: lead
• Fundacion Clinic per a la Recerca Biomédica: collaborator

Study Sites (1)

Hospital Clínic i Provincial de Barcelona

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 19, 2016
• Study Start: July 4, 2017
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

ES (1)