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

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

Detailed Description
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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.

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

Conditions
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Renal Transplantation

Intervention / Treatment
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* Drug: N-acetylcysteine
* Drug: control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-acetylcysteine<br>N-acetylcysteine 600 mg bid po 0-7 PO | Drug: N-acetylcysteine<br>* 600 mg bid po 0-7 PO<br>* Other names: Fluimucil;|
| Sham Comparator: control<br>No treatment: standard care provided. No N-acetylcysteine administration. | Drug: control<br>* No treatment: standard care provided. No N-acetylcysteine administration.<br>* Other names: N/A (not applicable);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplantation, oxidative stress, acetylcysteine, graft rejection