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) (NICIR)

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

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 Overview

• Status: Completed
• Conditions: Renal Insufficiency
• Intervention / Treatment: Other: Oral hydratation; Drug: Bicarbonate endovenous hydratation; Drug: Saline endovenous hydratation

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital Clinic i Provincial de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral hydratation	Other: Oral hydratation; 500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography
Active Comparator: Endovenous hydratation	Drug: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for hemodialysis	Need for hemodialysis for one month after completion of the computed tomography, among patients who have undergone oral or intravenous hydration	15 days
Reversibility of contrast induced nephropathy	Defined as no increase in creatinine> 0.5 mg / dl compared to the initial analysis performed	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	15 days

Collaborators and Investigators

• Sponsor: David Garcia Cinca
• Collaborators: Fundacion Clinic per a la Recerca Biomédica

Publications and helpful links

Helpful Links

• Oral hydration compared to intravenous hydration in the prevention of post-contrast acute kidney injury in patients with chronic kidney disease stage IIIb: A phase III non-inferiority study (NICIR study)

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2017
• Primary Completion (Actual): July 15, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: computed tomography; renal insufficiency; contrast-induced nephropathy
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency
• Other Study ID Numbers: NICIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No