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

Institut d'Anesthesiologie des Alpes Maritimes

Status and phase: Completed; Phase 3

Conditions: Brain Death; Chronic Renal Insufficiency

Treatments: Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT00998972

NAC-CHUN1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all recipient for kidney graft in our hospital

Exclusion criteria

• transplantation out side our hospital
• refusal from the patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

control

No Intervention group

Description:

control arm without any specific intervention

N-acetylcysteine

Experimental group

Description:

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

Treatment:

Drug: N-acetylcysteine