Clinical trial NCT00998972: N-acetyl-cysteine (NAC) and Kidney Graft Function
Official title: Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Death
Chronic Renal Insufficiency
Keywords: kidney graft,
delayed graft function
N-acetylcysteine
Lead sponsor: Institut d'Anesthesiologie des Alpes Maritimes
Sponsor class: OTHER
First posted: 2009-10-21
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* all recipient for kidney graft in our hospital

Exclusion Criteria:

* transplantation out side our hospital
* refusal from the patient

Primary outcomes:
measure: Incidence of delayed graft function
timeFrame: 1 year
Secondary outcomes:
measure: Evolution of creatininemia and azotemia during the first month after transplantation
timeFrame: 30 days
measure: Intrahospital mortality
timeFrame: 30 days
measure: Acute and delayed graft rejection
timeFrame: 30 days
Other outcomes:
Locations:
city: NICE cedex 01
country: France
facility: CHU de Nice
state: Alpes Maritimes
Study officials:
affiliation: Service de Reanimation Medicochirurgical. CHU de Nice
name: Carole R Ichai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orban JC, Quintard H, Cassuto E, Jambou P, Samat-Long C, Ichai C. Effect of N-acetylcysteine pretreatment of deceased organ donors on renal allograft function: a randomized controlled trial. Transplantation. 2015 Apr;99(4):746-53. doi: 10.1097/TP.0000000000000395.