NCT00851708

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.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
Last Updated

March 2, 2009

Status Verified

February 1, 2009

First QC Date

February 25, 2009

Last Update Submit

February 27, 2009

Conditions

Deceased Kidney Transplantation

Keywords

kidneydeceased kidney transplantoxidative stressrenal function measurements

Outcome Measures

Primary Outcomes (1)

  • Tiobarbituric acid reactive species measures

    First seven postoperative days

Secondary Outcomes (1)

  • Serum creatinine

    7, 15, 30, 60, 90 postoperative day

Study Arms (2)

NAC

ACTIVE COMPARATOR

treatment

Drug: N-acetylcysteine

control

NO INTERVENTION

Interventions

N-acetylcysteineDRUG

600 mg bid orally from day 1 to 7 postoperative

NAC

Eligibility Criteria

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

You may qualify if:

  • First transplant
  • Deceased kidney transplant

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinics Hospital, University of Sao Paulo, Medical School

São Paulo, São Paulo, 05403-001, Brazil

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Last Updated

March 2, 2009

Record last verified: 2009-02

Locations

BR(1)