Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Contrast Induced Nephropathy Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Sodium bicarbonate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No