Role of Acetylcysteine in Creatinine Clearance

November 3, 2006 updated by: Eastern Virginia Medical School
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Eastern Virginia Medical School/Nephrology Associates
        • Principal Investigator:
          • Thomas R. McCune, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Virginia Medical School

Investigators

  • Principal Investigator: Thomas R McCune, MD, Eastern Virginia Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Registration Dates

First Submitted

November 3, 2006

First Submitted That Met QC Criteria

November 3, 2006

First Posted (ESTIMATE)

November 6, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2006

Last Update Submitted That Met QC Criteria

November 3, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVMS 06-03-FB-0044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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