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Completed

NCT Number: NCT00312117

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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Key information

Conditions

Contrast Induced Nephropathy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaiser Permanente Medical Center

Los Angeles, California, 90027, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium bicarbonate

Drug

Primary outcomes

  1. development of contrast induced nephropathy, defined by a decrease in glomerular filtration rate (GFR) by 25% or more

Secondary outcomes

  1. change in serum creatinine

  2. difference in hospital duration between groups

  3. need for hemodialysis

  4. 30 day mortality

  5. difference of baseline to lowest GFR and highest creatinine between groups

  6. difference in GFR and creatinine from baseline and 2-8 weeks later

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

A Randomized Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Important dates

Study start
2006
Study completion
2006
First posted
Apr 7, 2006
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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