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)

Renal Insufficiency Clinical Trial

— NICIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872155
• Other study ID #: NICIR
• Status: Completed
• Phase: Phase 3
• Start date: July 4, 2017
• Est. completion date: July 15, 2019

Study information

• Verified date: January 2021
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency

Intervention

Other:
• Oral hydratation
500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
David Garcia Cinca	Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Reversibility of contrast induced nephropathy	Defined as no increase in creatinine> 0.5 mg / dl compared to the initial analysis performed	15 days
Secondary	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

External 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)