Role of Acetylcysteine in Creatinine Clearance

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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The purpose of this study is to investigate the exact role of Acetylcysteine (Mucomyst) in altering creatinine clearance. Prior studies have shown the protective effects of Acetylcysteine on contrast-induced renal dysfunction. In these studies, Acetylcysteine lowered the incidence of serum creatinine elevation after administration of radiographic contrast agents. Not only was the increase in serum creatinine prevented, the studies also demonstrated a significant increase in creatinine clearance after administration of the agent. These prior studies did not evaluate if the increase in creatinine clearance was indeed from a protective benefit of Acetylcysteine in preserving the GFR versus simply increasing the proximal tubular creatinine secretion without actually affecting the GFR. We propose an experiment to help support our hypothesis that Acetylcysteine increases creatinine clearance via an increase in proximal tubular secretion of creatinine.

Detailed Description

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Conditions

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Creatinine Clearance

Keywords

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Creatinine clearance Acetylcysteine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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Acetylcysteine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Between the ages of 18 and 79 years
2. In good general health
3. Able to provide informed consent

Exclusion Criteria

1. Allergy to acetylcysteine or cimetidine,
2. Age less than 18 years or greater than 79 years of age,
3. Women of childbearing age and not able to use adequate contraception, or 4. Anyone currently on any medication that interferes with tubular secretion of creatinine such as trimethoprim-sulfamethoxazole (Bactrim).

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Thomas R McCune, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

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Eastern Virginia Medical School/Nephrology Associates

Norfolk, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ritche Chiu, MD

Role: CONTACT

Phone: 757-680-0211

Email: [email protected]

Michael J Bradley, MD