Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate
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Purpose
Contrast nephropathy (CN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity/mortality, and cost. In addition, these patients may require temporary or permanent hemodialysis which, in turn, is associated with further morbidity, mortality, and cost. CN has been reported to account for 10% of hospital acquired renal failure. In recent years, studies have investigated preventive therapies with mixed results. Fenoldopam was found to be ineffective in a large randomized trial. Dopamine has been shown to be ineffective as a preventive strategy. Hemofiltration has been shown to be beneficial (New England Journal of Medicine [NEJM] 2003) but is costly and not practical. Mucomyst has shown mixed results. The single strategy which most would agree as being beneficial remains hydration, most commonly with intravenous 0.9% normal saline. Most recently, sodium bicarbonate has been shown to be beneficial in a small randomized trial (n=119). It is clear that the most cost effective strategies for treatment of CN should be aimed at prevention.
The general question is: "Is a sodium bicarbonate solution more efficacious in preventing contrast nephropathy compared to normal saline?" The general hypothesis is that sodium bicarbonate will be more efficacious.
| Condition | Intervention | Phase |
|---|---|---|
|
Contrast Induced Nephropathy Kidney Diseases |
Drug: Sodium bicarbonate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Randomized Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate |
- development of contrast induced nephropathy, defined by a decrease in glomerular filtration rate (GFR) by 25% or more
- change in serum creatinine
- difference in hospital duration between groups
- need for hemodialysis
- 30 day mortality
- difference of baseline to lowest GFR and highest creatinine between groups
- difference in GFR and creatinine from baseline and 2-8 weeks later
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2006 |
| Study Completion Date: | February 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
- GFR < 60 mL/min/1.73m2. GFR will be adjusted by a correction factor as reported by our laboratory for patients self identifying as black.
- > 18 years and have at least one of the following risk factors for contrast nephropathy: diabetes (type 2), congestive heart failure, hypertension (> 140/90), or age > 75.
- Both inpatients and outpatients will be offered enrollment.
Exclusion Criteria:
- Patients unable to give consent
- Already receiving sodium bicarbonate solution
- Undergoing emergency cardiac catheterization
- Receiving a contrast agent other than Oxilan
- On hemodialysis
- Recent exposure to contrast within 2 days
- Pulmonary edema
- Active congestive heart failure
- Severe valvular abnormality
- Recent significant change in kidney function (> 15% over 2d)
- One kidney
- Kidney transplant status
Contacts and Locations| United States, California | |
| Kaiser Permanente Medical Center | |
| Los Angeles, California, United States, 90027 | |
| Principal Investigator: | Somjot S Brar, M.D. | Kaiser Permanente Southern California |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00312117 History of Changes |
| Other Study ID Numbers: | 4353 |
| Study First Received: | April 5, 2006 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kaiser Permanente:
|
contrast induced nephropathy sodium bicarbonate cardiac catheterization |
Additional relevant MeSH terms:
|
Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013