NCT00994305

Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients.

Detailed description

Investigate the therapeutic effects of 600 mg bid po of N-acetylcysteine on early outcomes of deceased renal transplant patients regarding oxidative stress and renal function. Adult primary graft recipients of deceased renal donors will be randomly assign to treatment (NAC) or control group and prospectively evaluated for 90 days. Treatment group will receive N-acetylcysteine 600 mg bid po from 0 to 7th postoperative day (PO). Renal function will be determined by serum creatinine, Cockroft-Gault estimated GFR (eGFR) at 7th, 15th, 30th, 60th and 90th PO and dialysis free Kaplan-Meier estimate curve. Serum levels of thiobarbituric acid reactive substances (TBARS), which are markers of lipid peroxidation and oxidative stress, will be determined using the thiobarbituric acid assay from 0-7th PO. Statistical analysis will be performed using SPSS 16.0.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	N-acetylcysteine	600 mg bid po 0-7 PO
DRUG	control	No treatment: standard care provided. No N-acetylcysteine administration.

Timeline

• Start date: 2005-04-01
• Primary completion: 2008-06-01
• Completion: 2009-12-01
• First posted: 2009-10-14
• Last updated: 2009-10-14

Locations

1 site across 1 country: Brazil