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

Primary Purpose

Brain Death, Chronic Renal Insufficiency

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
Institut d'Anesthesiologie des Alpes Maritimes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Death focused on measuring kidney graft,, delayed graft function, N-acetylcysteine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all recipient for kidney graft in our hospital

Exclusion Criteria:

  • transplantation out side our hospital
  • refusal from the patient

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

N-acetylcysteine

Arm Description

control arm without any specific intervention

administration of 600 mg intravenous N-acetyl cysteine before and 2 hours after angiography performed for the diagnosis of brain death

Outcomes

Primary Outcome Measures

Incidence of delayed graft function

Secondary Outcome Measures

Evolution of creatininemia and azotemia during the first month after transplantation
Intrahospital mortality
Acute and delayed graft rejection

Full Information

First Posted
October 17, 2009
Last Updated
July 9, 2011
Sponsor
Institut d'Anesthesiologie des Alpes Maritimes
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1. Study Identification

Unique Protocol Identification Number
NCT00998972
Brief Title
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

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut d'Anesthesiologie des Alpes Maritimes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death, Chronic Renal Insufficiency
Keywords
kidney graft,, delayed graft function, N-acetylcysteine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
control arm without any specific intervention
Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
administration of 600 mg intravenous N-acetyl cysteine before and 2 hours after angiography performed for the diagnosis of brain death
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
n-acetylcysteine administration
Intervention Description
600 mg intravenous before and 2 hours after cerebral arteriography
Primary Outcome Measure Information:
Title
Incidence of delayed graft function
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evolution of creatininemia and azotemia during the first month after transplantation
Time Frame
30 days
Title
Intrahospital mortality
Time Frame
30 days
Title
Acute and delayed graft rejection
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all recipient for kidney graft in our hospital Exclusion Criteria: transplantation out side our hospital refusal from the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole R Ichai, MD, PhD
Organizational Affiliation
Service de Reanimation Medicochirurgical. CHU de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
NICE cedex 01
State/Province
Alpes Maritimes
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25250647
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.
Results Reference
derived

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

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