Chronic Renal Insufficiency Clinical Trial
Official title:
Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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