Impact of N-Acetylcysteine on Oxidative Stress and Renal Function in Deceased Kidney Transplant Recipients

February 27, 2009 updated by: University of Sao Paulo

Oxidative Stress and Postoperatory Renal Function in Deceased Kidney Transplantation

The aim of this interventional, prospective, randomized clinical trial is to evaluate the impact of the antioxidant N-acetylcysteine on oxidative stress in the first seven postoperative days and on renal function in the first three postoperative months in deceased kidney transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Brazil
      • São Paulo, Brazil, 05403-001
        • Clinics Hospital, University of Sao Paulo, Medical School

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First transplant
  • Deceased kidney transplant

Exclusion Criteria:

  • postoperative recovery at critical care unit
  • illicit drug addiction
  • psychiatric disorders

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Active Comparator: NAC
treatment
Drug: N-acetylcysteine
600 mg bid orally from day 1 to 7 postoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tiobarbituric acid reactive species measures
Time Frame: First seven postoperative days
First seven postoperative days

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum creatinine
Time Frame: 7, 15, 30, 60, 90 postoperative day
7, 15, 30, 60, 90 postoperative day

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

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 Registration Dates

First Submitted

February 25, 2009

First Submitted That Met QC Criteria

February 25, 2009

First Posted (Estimate)

February 26, 2009

Study Record Updates

Last Update Posted (Estimate)

March 2, 2009

Last Update Submitted That Met QC Criteria

February 27, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAC vs DKT
  • FAPESP 06/52046-0

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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