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

U

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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