N-acetyl-cysteine (NAC) and Kidney Graft Function
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function|
- Incidence of delayed graft function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Evolution of creatininemia and azotemia during the first month after transplantation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Intrahospital mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Acute and delayed graft rejection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2006|
|Study Completion Date:||June 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
No Intervention: control
control arm without any specific intervention
administration of 600 mg intravenous N-acetyl cysteine before and 2 hours after angiography performed for the diagnosis of brain death
600 mg intravenous before and 2 hours after cerebral arteriography
Other Name: n-acetylcysteine administration
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998972
|CHU de Nice|
|NICE cedex 01, Alpes Maritimes, France, 06000|
|Principal Investigator:||Carole R Ichai, MD, PhD||Service de Reanimation Medicochirurgical. CHU de Nice|