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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
  Purpose

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.


Condition Intervention Phase
Brain Death
Chronic Renal Insufficiency
Drug: N-acetylcysteine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function

Resource links provided by NLM:


Further study details as provided by Institut d'Anesthesiologie des Alpes Maritimes:

Primary Outcome Measures:
  • Incidence of delayed graft function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 236
Study Start Date: September 2006
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: N-acetylcysteine
600 mg intravenous before and 2 hours after cerebral arteriography
Other Name: n-acetylcysteine administration

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all recipient for kidney graft in our hospital

Exclusion Criteria:

  • transplantation out side our hospital
  • refusal from the patient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998972

Locations
France
CHU de Nice
NICE cedex 01, Alpes Maritimes, France, 06000
Sponsors and Collaborators
Institut d'Anesthesiologie des Alpes Maritimes
Investigators
Principal Investigator: Carole R Ichai, MD, PhD Service de Reanimation Medicochirurgical. CHU de Nice
  More Information

No publications provided

Responsible Party: Carole Ichai, Institut d'Anesthésiologie des AM
ClinicalTrials.gov Identifier: NCT00998972     History of Changes
Other Study ID Numbers: NAC-CHUN1
Study First Received: October 17, 2009
Last Updated: July 9, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Institut d'Anesthesiologie des Alpes Maritimes:
kidney graft,
delayed graft function
N-acetylcysteine

Additional relevant MeSH terms:
Brain Death
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Brain Diseases
Central Nervous System Diseases
Coma
Consciousness Disorders
Death
Kidney Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Unconsciousness
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014