A Phase 3 interventional study of N-acetylcysteine in Brain Death and Chronic Renal Insufficiency, sponsored by Institut d'Anesthesiologie des Alpes Maritimes. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-07-12.
Sponsored by Institut d'Anesthesiologie des Alpes Maritimes · Phase 3, Interventional, and Treatment
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.
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.
74 studies on the registry are indexed under Brain Death; 9 are open to participants now.
This study's enrollment of 236 is above the median of 46 across 37 interventional studies indexed under Brain Death.
Browse Brain Death studies →Institut d'Anesthesiologie des Alpes Maritimes is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: N-acetylcysteine
600 mg intravenous before and 2 hours after cerebral arteriography
Also known as: 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
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Institut d'Anesthesiologie des Alpes Maritimes