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The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sodium bicarbonate | Experimental | hydration with sodium bicarbonate |
|
| saline | Active Comparator | hydration with saline 1ml/Kg/h for 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium bicarbonate | Drug | hydration with sodium bicarbonate 1ml/Kg/h for 6 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-induced Nephropathy | rise in serum creatinine >0,5mg/dl | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis During Hospitalization | During hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| São Lucas Hospital - PUCRS University | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Bicarbonate | hydration with sodium bicarbonate sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours |
| FG001 | Saline | hydration with saline 1ml/Kg/h for 6 hours saline: hydration with saline 1ml/Kg/h for 6 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Bicarbonate | hydration with sodium bicarbonate sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours |
| BG001 | Saline | hydration with saline 1ml/Kg/h for 6 hours saline: hydration with saline 1ml/Kg/h for 6 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Contrast-induced Nephropathy | rise in serum creatinine >0,5mg/dl | Posted | Number | percentage of contrast nephropaty | 48 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Bicarbonate | hydration with sodium bicarbonate sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vitor Osório Gomes, MD, PhD | Hospital Sao Lucas | 55 51 33203494 | pesquisa@cardiarte.com.br |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| saline |
| Drug |
hydration with saline 1ml/Kg/h for 6 hours |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Dialysis During Hospitalization | Posted | Number | participants | During hospitalization |
|
|
|
| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | Saline | hydration with saline 1ml/Kg/h for 6 hours saline: hydration with saline 1ml/Kg/h for 6 hours | 0 | 151 | 0 | 151 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |