N-acetyl-cysteine (NAC) and Kidney Graft Function

Sponsor

Institut d'Anesthesiologie des Alpes Maritimes (Other)

Overall Status

Completed

CT.gov ID

NCT00998972

Collaborator

(none)

236

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to evaluate the effect of N-acetyl-cysteine (NAC) administration in organ donors on the kidney graft function of recipients.

Condition or Disease	Intervention/Treatment	Phase
Brain Death Chronic Renal Insufficiency	Drug: N-acetylcysteine	Phase 3

Detailed Description

Ischemia-reperfusion is a major contributing factor for delayed renal function after transplantation. It has been shown that the administration of an antioxidant, i.e. NAC, in patients with chronic renal insufficiency may prevent radio contrast-induced nephropathy. Due to its antioxidant effects, organ donor pretreatment with NAC has demonstrated to improve renal graft function in two experimental studies. Study objectives: to compare the incidence of delayed graft renal function between two groups of patients, i.e., those receiving the graft from organ donors pretreated with NAC and a group control. The primary endpoint was the number of delayed graft function defined as the requirement of at least one sequence of dialysis during the first seven days following transplantation. Secondary endpoints: evolution of creatininemia, azotemia at day 1, 7, 14 and ,30 after surgery; acute and delayed transplant rejection; intrahospital mortality.

Patients inclusion: all organ donors and recipients were eligible Exclusion criteria: for organ donors were preexistent chronic renal insufficiency and contra-indications for kidney procurement; for recipient were transplantation outside our hospital The donors were randomized in a single-blind fashion into two groups : the control group and the group receiving 600 mg IV of NAC 1 hour before and 600 mg IV 2 hours after cerebral arteriography required to diagnose brain death. Sample size has been calculated delayed graft function by 50% leading to include 118 recipients in each group.

Follow up: one year after transplantation. Study beginning in september 2006. Length of inclusion during 36 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

236 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control control arm without any specific intervention
Experimental: N-acetylcysteine administration of 600 mg intravenous N-acetyl cysteine before and 2 hours after angiography performed for the diagnosis of brain death	Drug: N-acetylcysteine 600 mg intravenous before and 2 hours after cerebral arteriography Other Names: n-acetylcysteine administration

Arm

Intervention/Treatment

No Intervention: control

control arm without any specific intervention

Experimental: N-acetylcysteine

administration of 600 mg intravenous N-acetyl cysteine before and 2 hours after angiography performed for the diagnosis of brain death

Drug: N-acetylcysteine

600 mg intravenous before and 2 hours after cerebral arteriography

Other Names:

n-acetylcysteine administration

Outcome Measures

Primary Outcome Measures

Incidence of delayed graft function [1 year]

Secondary Outcome Measures

Evolution of creatininemia and azotemia during the first month after transplantation [30 days]
Intrahospital mortality [30 days]
Acute and delayed graft rejection [30 days]