Study to compare the effectiveness of drinking water or receiving endovenous hydration to prevent complications in the kidney in patients with renal insufficiency grade III underwent performing computed tomography (CT)

Phase 1

• Conditions: Patients with renal failure undergoing a computed tomography scan with contrast; MedDRA version: 19.0Level: PTClassification code 10038435Term: Renal failureSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2016-002032-33-ES
• Lead Sponsor: Fundacio Privada Clinic per a la Recerca Biomedica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-15
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a) Patients of both sexes over 18 years
b) Candidates for a study with computed tomography and intravenous contrast
c) Pesenten a glomerular filtration rate between 30 and 45 mL / min including both determinations
d) 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 representative legally designated for inclusion in the clinical trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

a) refuse to participate in the study
b) Pregnancy or lactation
c) Other risk factors for Contrast Induced Nephropathy:
- Diabetes mellitus
- Have an age of 70 years or above
- Heart failure (defined by a scale New York Heart Association - NYHA 3 or 4)
- Hypotension (defined as systolic blood pressure <100)
- Being treated with nephrotoxic medications.
d) 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Check if oral hydration is at least as effective as intravenous hydration in reducing the appearance of contrast-induced nephropathy after performing a computed tomography with intravenous contrast in patients with renal insufficiency grade III.;Secondary Objective: - Analyze the need for hemodialysis for one month after completion of computed tomography in patients who have undergone oral or intravenous hydration.<br>- Analyze the reversibility of the contrast-induced nephropathy 15 days, in patients that have presented at 3 days post computed tomography, in both hydration groups<br>- Assess safety in both groups hydration;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 48-72 hours after the completion of the computed tomography

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a) Need for hemodialysis for one month after completion of the computed tomography, among patients who have undergone oral or intravenous hydration.<br>b) Reversibility of contrast induced nephropathy 15 days of computed tomography, defined as no increase in creatinine> 0.5 mg / dl compared to the initial analysis performed 15 days after the completion of the analytical computed tomography.<br>c) Presence of adverse events, grade 3 adverse events and serious adverse events related to the investigational products during the study follow-up.;Timepoint(s) of evaluation of this end point: 15 days