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Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00312117
First Posted: April 7, 2006
Last Update Posted: March 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kaiser Permanente
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Randomized Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • development of contrast induced nephropathy, defined by a decrease in glomerular filtration rate (GFR) by 25% or more

Secondary Outcome Measures:
  • 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312117


Locations
United States, California
Kaiser Permanente Medical Center
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Somjot S Brar, M.D. Kaiser Permanente Southern California
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00312117     History of Changes
Other Study ID Numbers: 4353
First Submitted: April 5, 2006
First Posted: April 7, 2006
Last Update Posted: March 11, 2015
Last Verified: March 2015

Keywords provided by Kaiser Permanente:
contrast induced nephropathy
sodium bicarbonate
cardiac catheterization

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases