Trial record 1 of 1 for:    NCT00312117
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Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

This study has been completed.
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00312117
First received: April 5, 2006
Last updated: July 23, 2008
Last verified: July 2008

April 5, 2006
July 23, 2008
January 2006
Not Provided
development of contrast induced nephropathy, defined by a decrease in glomerular filtration rate (GFR) by 25% or more
Development of contrast induced nephropathy, defined by a decrease in GFR by 25% or more.
Complete list of historical versions of study NCT00312117 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
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Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate
A Randomized Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Contrast Induced Nephropathy
  • Kidney Diseases
Drug: Sodium bicarbonate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
February 2006
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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
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00312117
4353
Yes
Not Provided
Kaiser Permanente
Not Provided
Principal Investigator: Somjot S Brar, M.D. Kaiser Permanente Southern California
Kaiser Permanente
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP