Role of Acetylcysteine in Creatinine Clearance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Eastern Virginia Medical School.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT00396396
First received: November 3, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396396

Contacts
Contact: Ritche Chiu, MD 757-680-0211 ext Pager dr_ritchechiu@yahoo.com
Contact: Michael J Bradley, MD 757-554-5578 ext Pager BradleMJ@evms.edu

Locations
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
Investigators
Principal Investigator: Thomas R McCune, MD Eastern Virginia Medical School
  More Information

No publications provided

ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:
Creatinine clearance
Acetylcysteine

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on April 23, 2014