NCT00396396

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2006

Completed
Last Updated

November 6, 2006

Status Verified

November 1, 2006

First QC Date

November 3, 2006

Last Update Submit

November 3, 2006

Conditions

Creatinine Clearance

Keywords

Creatinine clearanceAcetylcysteine

Interventions

AcetylcysteineDRUG

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18 and 79 years
  • In good general health
  • Able to provide informed consent

You may not qualify if:

  • Allergy to acetylcysteine or cimetidine,
  • Age less than 18 years or greater than 79 years of age,
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Virginia Medical School/Nephrology Associates

Norfolk, Virginia, 23507, United States

RECRUITING

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Thomas R McCune, MD

    Eastern Virginia Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ritche Chiu, MD

CONTACT

757-680-0211dr_ritchechiu@yahoo.com

Michael J Bradley, MD

CONTACT

757-554-5578BradleMJ@evms.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2006

First Posted

November 6, 2006

Study Start

October 1, 2006

Last Updated

November 6, 2006

Record last verified: 2006-11

Locations

US(1)