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N-acetyl-cysteine (NAC) and Kidney Graft Function

This study has been completed.
Sponsor:
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes
ClinicalTrials.gov Identifier:
NCT00998972
First received: October 17, 2009
Last updated: July 9, 2011
Last verified: June 2009
History of Changes

October 17, 2009
July 9, 2011
September 2006
December 2010   (final data collection date for primary outcome measure)
Incidence of delayed graft function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00998972 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
N-acetyl-cysteine (NAC) and Kidney Graft Function
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Brain Death
  • Chronic Renal Insufficiency
Drug: N-acetylcysteine
600 mg intravenous before and 2 hours after cerebral arteriography
Other Name: n-acetylcysteine administration
  • No Intervention: control
    control arm without any specific intervention
  • Experimental: N-acetylcysteine
    administration of 600 mg intravenous N-acetyl cysteine before and 2 hours after angiography performed for the diagnosis of brain death
    Intervention: Drug: N-acetylcysteine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
236
June 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all recipient for kidney graft in our hospital

Exclusion Criteria:

  • transplantation out side our hospital
  • refusal from the patient
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00998972
NAC-CHUN1
No
Carole Ichai, Institut d'Anesthésiologie des AM
Institut d'Anesthesiologie des Alpes Maritimes
Not Provided
Principal Investigator: Carole R Ichai, MD, PhD Service de Reanimation Medicochirurgical. CHU de Nice
Institut d'Anesthesiologie des Alpes Maritimes
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP