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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Renal Transplantation

Treatments: Drug: control; Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT00994305

NACTX

FAPESP 06/52046-0

CAPPesq 076/05

Details and patient eligibility

About

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

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

N-acetylcysteine

Active Comparator group

Description:

N-acetylcysteine 600 mg bid po 0-7 PO

Treatment:

Drug: N-acetylcysteine

control

Sham Comparator group

Description:

No treatment: standard care provided. No N-acetylcysteine administration.

Treatment:

Drug: control