Role of Acetylcysteine in Creatinine Clearance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00396396
Recruitment Status : Unknown
Verified November 2006 by Eastern Virginia Medical School.
Recruitment status was:  Recruiting
First Posted : November 6, 2006
Last Update Posted : November 6, 2006
Information provided by:
Eastern Virginia Medical School

Brief Summary:
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 or disease Intervention/treatment Phase
Creatinine Clearance Drug: Acetylcysteine Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine
U.S. FDA Resources

Information from the National Library of Medicine

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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00396396     History of Changes
Other Study ID Numbers: EVMS 06-03-FB-0044
First Posted: November 6, 2006    Key Record Dates
Last Update Posted: November 6, 2006
Last Verified: November 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