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This will be a randomized controlled trial closely following the original protocol in the previous study published in JAMA 2004 by Merten et al. Patients will be randomly assigned to one of two treatment groups. Treatment group A will receive 1cc/kg/hour of 0.9% normal saline at least 2 hours prior to study beginning and will be continued during and for 6 hours post contrast. Treatment group B will receive 3cc/kg of sodium bicarbonate solution for one hour prior to procedure then drip rate will be decreased to 1cc/kg/hour during and for 6 hours post procedure. The sodium bicarbonate solution will be made by adding 3 amps of bicarbonate to 1L of D5W. Patients in both treatment arms weighing >110kg the initial fluid bolus and drip will be limited to those patients weighing 110kg. In both treatment arms, diuretics will be held before and after contrast administration on the day of the study. BMP will be checked the day of, 24 and 48 hours post contrast administration. The greatest change in all readings will be used for treatment comparisons. Contrast induced nephropathy will be defined as a change in serum creatinine of more than 25% from baseline and/or 0.5mg/dL. Urinary pH will also be measured on first spontaneous void following bolus. Vital signs including blood pressure and oxygen saturation will be documented every 4 hours to monitor patients closely for signs and symptoms of volume overload
Inclusion Criteria:
Exclusion Criteria
Subjects: Consecutive samples of all CPSC inpatients who meet the above inclusion criteria
Allocation Assignment: Patients who meet inclusion criteria and agree to participate in the study will pick a concealed number out of an open envelope. That number (between 1- 656) will correlate with a number on a sealed opaque envelope. Inside the opaque envelope will be a chart sticker. The chart sticker will have the words either normal saline or sodium bicarbonate. The envelope will not be opened until all patient information (ie. Patient ID sticker) is placed on the original chosen envelope. Then the chart sticker will be removed and placed on the chart
Protocol Outline:
This will be a randomized controlled trial closely following the original protocol in the previous study. Patients will be randomly assigned to one of two treatment groups. Treatment group A will receive 1cc/kg/hour of 0.9% normal saline at least 2 hours prior to study beginning and will be continued during and for 6 hours post contrast. Treatment group B will receive 3cc/kg of sodium bicarbonate solution for one hour prior to procedure then drip rate will be decreased to 1cc/kg/hour during and for 6 hours post procedure. The sodium bicarbonate solution will be made by adding 3 amps of bicarbonate to 1L of D5W. Patients in both treatment arms weighing >110kg the initial fluid bolus and drip will be limited to those patients weighing 110kg. In both treatment arms, diuretics will be held before and after contrast administration on the day of the study. BMP will be checked the day of, 24 and 48 hours post contrast administration. The greatest change in all readings will be used for treatment comparisons. Contrast induced nephropathy will be defined as a change in serum creatinine of more than 25% from baseline and/or 0.5mg/dL. Urinary pH will also be measured on first spontaneous void following bolus. Vital signs including blood pressure and oxygen saturation will be documented every 4 hours to monitor patients closely for signs and symptoms of volume overload
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 amps of sodium bicarbonate mixed in one liter of D5W | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast |
| Measure | Description | Time Frame |
|---|---|---|
| change in mean arterial pressure after initial bolus, mmHg | ||
| urine pH after initial bolus | ||
| contrast volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donna S Sanders, DO | Contact | 276-708-7021 | dsanders_nch@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Donna S Sanders, DO | Norton Community Hospital | Principal Investigator |
| Mathew Cusano, MD | Norton Community Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Community Hospital | Norton | Virginia | 24273 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15150204 | Background | Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328. | |
| 16436769 | Background |
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| change in serum bicarbonate |
| change in serum potassium |
| change in serum glucose |
| change in serum creatinine |
| change in estimated glomerular filtration rate |
| incidence of contrast induced nephropathy |
| Barrett BJ, Parfrey PS. Clinical practice. Preventing nephropathy induced by contrast medium. N Engl J Med. 2006 Jan 26;354(4):379-86. doi: 10.1056/NEJMcp050801. No abstract available. |