Renal Insufficiency
Conditions
Keywords
contrast-induced nephropathy, renal insufficiency, computed tomography
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.
Interventions
OTHEROral hydratation
500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography
DRUGBicarbonate 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.
DRUGSaline 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.
Sponsors
Fundacion Clinic per a la Recerca Biomédica
David Garcia Cinca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of contrast induced nephropathy | 48-72 hours after the completion of the computed tomography | 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
| Measure | Time frame | Description |
|---|---|---|
| Need for hemodialysis | 15 days | 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 | 15 days | Defined as no increase in creatinine\> 0.5 mg / dl compared to the initial analysis performed |
| Proportion of adverse events | 15 days | Presence of adverse events, grade 3 adverse events and serious adverse events related to the investigational products during the study follow-up |
Countries
Spain
Outcome results
None listed