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

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ClinicalTrials.gov Identifier: NCT00851708
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : March 2, 2009
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Deceased Kidney Transplantation Drug: N-acetylcysteine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: Oxidative Stress and Postoperatory Renal Function in Deceased Kidney Transplantation

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NAC
treatment
Drug: N-acetylcysteine
600 mg bid orally from day 1 to 7 postoperative

No Intervention: control



Primary Outcome Measures :
  1. Tiobarbituric acid reactive species measures [ Time Frame: First seven postoperative days ]

Secondary Outcome Measures :
  1. Serum creatinine [ Time Frame: 7, 15, 30, 60, 90 postoperative day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First transplant
  • Deceased kidney transplant

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851708


Locations
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Brazil
Clinics Hospital, University of Sao Paulo, Medical School
São Paulo, Brazil, 05403-001
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo

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Responsible Party: Antonio Marmo Lucon, University of São Paulo
ClinicalTrials.gov Identifier: NCT00851708     History of Changes
Other Study ID Numbers: NAC vs DKT
FAPESP 06/52046-0
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: March 2, 2009
Last Verified: February 2009
Keywords provided by University of Sao Paulo:
kidney
deceased kidney transplant
oxidative stress
renal function measurements
Additional relevant MeSH terms:
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Death
Pathologic Processes
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes