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| Tracking Information | |||||||||
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| First Received Date † | October 25, 2006 | ||||||||
| Last Updated Date | October 25, 2006 | ||||||||
| Start Date † | November 2006 | ||||||||
| Current Primary Outcome Measures † |
Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures † |
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| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate | ||||||||
| Official Title † | Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate | ||||||||
| Brief Summary | 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 |
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| Detailed Description | 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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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition † | Contrast Induced Nephropathy | ||||||||
| Intervention † | Drug: 3 amps of sodium bicarbonate mixed in one liter of D5W | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Enrollment † | 656 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00392405 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Norton Community Hospital | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Norton Community Hospital | ||||||||
| Verification Date | October 2006 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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