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

Not Applicable

• Conditions: Renal Transplantation
• Interventions: Drug: N-acetylcysteine; Drug: control

• Registration Number: NCT00994305
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2008-06
• Status Verified: 2009-10
• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-10-13
• Last Update Submitted: 2009-10-13
• Study First Posted: 2009-10-14
• Last Update Posted: 2009-10-14
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• primary deceased renal transplant recipients
• adult (>18 yo)

Exclusion Criteria

• unable to drink N-acetylcysteine during the first 7 PO
• participation in other study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Oxidative stress: measure of the oxidative stress generated after the deceased renal transplant by laboratorial serum measure of Thiobarbituric Acid Reactive Substances (TBARS) with the Trichloroacetic acid method.	7 days

Secondary Outcome Measures

Name	Time	Method
Graft function: measure of serum creatinine	3 months
Graft function:estimated creatinine clearance by Cokcroft-Gault formula	3 months
Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant	3 months

Trial Locations

Locations (1)

University of Sao Paulo General Hospital Kidney Transplant Unit; 🇧🇷 Sao Paulo, Brazil