Back to resultsComparative 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)
Primary Purpose
Renal Insufficiency
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Oral hydratation
Bicarbonate endovenous hydratation
Saline endovenous hydratation
Sponsored by
About this trial
This is an interventional prevention trial for Renal Insufficiency focused on measuring contrast-induced nephropathy, renal insufficiency, computed tomography
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.
Sites / Locations
- Hospital Clínic i Provincial de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oral hydratation
Endovenous hydratation
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Need for hemodialysis
Need for hemodialysis for one month after completion of the computed tomography, among patients who have undergone oral or intravenous hydration
Reversibility of contrast induced nephropathy
Defined as no increase in creatinine> 0.5 mg / dl compared to the initial analysis performed
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
Full Information
NCT ID
NCT02872155
First Posted
August 16, 2016
Last Updated
January 28, 2021
Sponsor
David Garcia Cinca
Collaborators
Fundacion Clinic per a la Recerca Biomédica
1. Study Identification
Unique Protocol Identification Number
NCT02872155
Brief Title
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)
Acronym
NICIR
Official Title
Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 4, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Garcia Cinca
Collaborators
Fundacion Clinic per a la Recerca Biomédica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
Keywords
contrast-induced nephropathy, renal insufficiency, computed tomography
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral hydratation
Arm Type
Experimental
Arm Title
Endovenous hydratation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Oral hydratation
Intervention Description
500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography
Intervention Type
Drug
Intervention Name(s)
Bicarbonate endovenous hydratation
Intervention Description
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
Intervention Name(s)
Saline endovenous hydratation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of contrast induced nephropathy
Description
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
Time Frame
48-72 hours after the completion of the computed tomography
Secondary Outcome Measure Information:
Title
Need for hemodialysis
Description
Need for hemodialysis for one month after completion of the computed tomography, among patients who have undergone oral or intravenous hydration
Time Frame
15 days
Title
Reversibility of contrast induced nephropathy
Description
Defined as no increase in creatinine> 0.5 mg / dl compared to the initial analysis performed
Time Frame
15 days
Title
Proportion of adverse events
Description
Presence of adverse events, grade 3 adverse events and serious adverse events related to the investigational products during the study follow-up
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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)
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