Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Phase 3

Completed

• Conditions: Contrast Induced Nephropathy; Kidney Diseases

• Registration Number: NCT00312117
• Lead Sponsor: Kaiser Permanente

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study Completion: 2006-02
• Study First Submitted: 2006-04-05
• Study First Submitted QC: 2006-04-05
• Study First Posted: 2006-04-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
difference in GFR and creatinine from baseline and 2-8 weeks later
change in serum creatinine
difference in hospital duration between groups
difference of baseline to lowest GFR and highest creatinine between groups
30 day mortality
need for hemodialysis

Trial Locations

Locations (1)

Kaiser Permanente Medical Center; 🇺🇸 Los Angeles, California, United States