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

Primary Purpose

Deceased Kidney Transplantation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deceased Kidney Transplantation focused on measuring kidney, deceased kidney transplant, oxidative stress, renal function measurements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First transplant
  • Deceased kidney transplant

Exclusion Criteria:

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

Sites / Locations

  • Clinics Hospital, University of Sao Paulo, Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

NAC

control

Arm Description

treatment

Outcomes

Primary Outcome Measures

Tiobarbituric acid reactive species measures

Secondary Outcome Measures

Serum creatinine

Full Information

First Posted
February 25, 2009
Last Updated
February 27, 2009
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00851708
Brief Title
Impact of N-Acetylcysteine on Oxidative Stress and Renal Function in Deceased Kidney Transplant Recipients
Official Title
Oxidative Stress and Postoperatory Renal Function in Deceased Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deceased Kidney Transplantation
Keywords
kidney, deceased kidney transplant, oxidative stress, renal function measurements

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
NAC
Arm Type
Active Comparator
Arm Description
treatment
Arm Title
control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
600 mg bid orally from day 1 to 7 postoperative
Primary Outcome Measure Information:
Title
Tiobarbituric acid reactive species measures
Time Frame
First seven postoperative days
Secondary Outcome Measure Information:
Title
Serum creatinine
Time Frame
7, 15, 30, 60, 90 postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First transplant Deceased kidney transplant Exclusion Criteria: postoperative recovery at critical care unit illicit drug addiction psychiatric disorders
Facility Information:
Facility Name
Clinics Hospital, University of Sao Paulo, Medical School
City
São Paulo
ZIP/Postal Code
05403-001
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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