N-acetyl-cysteine (NAC) and Kidney Graft Function
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|ClinicalTrials.gov Identifier: NCT00998972|
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : July 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Brain Death Chronic Renal Insufficiency||Drug: N-acetylcysteine||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||236 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||June 2011|
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
- Incidence of delayed graft function [ Time Frame: 1 year ]
- Evolution of creatininemia and azotemia during the first month after transplantation [ Time Frame: 30 days ]
- Intrahospital mortality [ Time Frame: 30 days ]
- Acute and delayed graft rejection [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|