Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral hydratation | Experimental |
| |
| Endovenous hydratation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral hydratation | Other | 500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic i Provincial de Barcelona | Barcelona | 08003 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bicarbonate endovenous hydratation | Drug | 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 | Drug | 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. |
|
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 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided