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Role of Acetylcysteine in Creatinine Clearance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Eastern Virginia Medical School.
Recruitment status was:  Recruiting
Information provided by:
Eastern Virginia Medical School Identifier:
First received: November 3, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
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.

Condition Intervention
Creatinine Clearance
Drug: Acetylcysteine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label

Resource links provided by NLM:

Further study details as provided by Eastern Virginia Medical School:

Estimated Enrollment: 35
Study Start Date: October 2006

Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00396396

Contact: Ritche Chiu, MD 757-680-0211 ext Pager
Contact: Michael J Bradley, MD 757-554-5578 ext Pager

United States, Virginia
Eastern Virginia Medical School/Nephrology Associates Recruiting
Norfolk, Virginia, United States, 23507
Principal Investigator: Thomas R. McCune, MD         
Sponsors and Collaborators
Eastern Virginia Medical School
Principal Investigator: Thomas R McCune, MD Eastern Virginia Medical School
  More Information Identifier: NCT00396396     History of Changes
Other Study ID Numbers: EVMS 06-03-FB-0044
Study First Received: November 3, 2006
Last Updated: November 3, 2006

Keywords provided by Eastern Virginia Medical School:
Creatinine clearance

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes processed this record on March 28, 2017