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| Name | Class |
|---|---|
| West Penn Allegheny Health System | OTHER |
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The increased risk for contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) undergoing coronary angiography (CAG) has been established. Current and historical data on CIN prevention strategies have shown wide variation with respect to the optimal type, route and timing of these therapies. We investigate the role for oral hydration and/or oral sodium bicarbonate administration compared to intravenous hydration and/or sodium bicarbonate in patients with CKD undergoing CAG.
This is a single center study randomizing patients with CKD undergoing CAG into 4 groups: 1) Intravenous normal saline, 2) Intravenous normal saline and intravenous bicarbonate, 3) oral hydration, and 4) oral hydration and oral bicarbonate. The primary endpoint was the occurrence of contrast-medium-induced nephropathy defined as greater than 25% increase in serum creatinine from baseline or an absolute increase of 0.5 mg/dL from baseline at 72 hours following exposure to radiocontrast. Secondary endpoints include the length of hospitalization and in-house mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Hydration | Active Comparator | Pretreatment with a 3 mL/kg bolus of intravenous normal saline solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1ml/kg per for 6 hours after the procedure. |
|
| Intravenous hydration and sodium bicarbonate | Active Comparator | Pretreatment with a 3 mL/kg bolus of intravenous sodium bicarbonate solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1 mL/kg for 6 hours after the procedure. |
|
| Oral hydration | Active Comparator | Oral hydration with 500 mL of water to be started 4 hours prior to contrast exposure and stopped 2 hours prior to procedure followed by oral hydration with 600 mL of water post procedure |
|
| Oral hydration and oral sodium bicarbonate | Active Comparator | Oral hydration with 500 mL of water to be started 4 hours prior to procedure and stopped 2 hours prior to contrast exposure, with the addition of 3.9 grams (46.4 mEq) of oral sodium bicarbonate to be given 20 minutes prior to contrast exposure followed by 1.95 grams (30.4 mEq) of oral sodium bicarbonate 2 hours and 4 hours after the initial dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral hydration | Other | Oral hydration with 500 mL of water to be started 4 hours prior to contrast exposure and stopped 2 hours prior to procedure followed by oral hydration with 600 mL of water post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast Induced Nephropathy | Defined as greater than 25% increase in serum creatinine from baseline or an absolute increase of 0.5 mg/dL from baseline at 72 hours. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Defined as number of days in the hospital. | 72 hours |
| In-Hospital Mortality | Any cause of mortality | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Cho, MD MHSA | The Western Pennsylvania Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Oral sodium bicarbonate | Drug | Oral hydration with 500 mL of water to be started 4 hours prior to procedure and stopped 2 hours prior to contrast exposure, with the addition of 3.9 grams (46.4 mEq) of oral sodium bicarbonate to be given 20 minutes prior to contrast exposure followed by 1.95 grams (30.4 mEq) of oral sodium bicarbonate 2 hours and 4 hours after the initial dose |
|
| Intravenous Hydration | Other | Pretreatment with a 3 mL/kg bolus of intravenous normal saline solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1ml/kg per for 6 hours after the procedure. |
|
| Intravenous sodium bicarbonate | Drug | Pretreatment with a 3 mL/kg bolus of intravenous sodium bicarbonate solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1 mL/kg for 6 hours after the procedure. |
|
| Aspiration | Defined as oxygen saturation less than 92% by pulse oximetry. | 72 hours |
| Hypotension | Defined as a systolic blood pressure less than 100 mmHg by conventional measuring methods. | 72 hours |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |