N-acetyl-cysteine (NAC) and Kidney Graft Function
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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 |
- Incidence of delayed graft function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- 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 |
Inclusion Criteria:
- all recipient for kidney graft in our hospital
Exclusion Criteria:
- transplantation out side our hospital
- refusal from the patient
Contacts and Locations| France | |
| CHU de Nice | |
| NICE cedex 01, Alpes Maritimes, France, 06000 | |
| 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, Chronic Renal Insufficiency Brain Diseases Central Nervous System Diseases Nervous System Diseases Coma Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Death Pathologic Processes Kidney Diseases |
Urologic Diseases Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 16, 2013