Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
236 participants
INTERVENTIONAL
2006-09-30
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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control
control arm without any specific intervention
No interventions assigned to this group
N-acetylcysteine
administration of 600 mg intravenous N-acetyl cysteine before and 2 hours after angiography performed for the diagnosis of brain death
N-acetylcysteine
600 mg intravenous before and 2 hours after cerebral arteriography
Interventions
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N-acetylcysteine
600 mg intravenous before and 2 hours after cerebral arteriography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* refusal from the patient
18 Years
70 Years
ALL
No
Sponsors
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Institut d'Anesthesiologie des Alpes Maritimes
OTHER
Responsible Party
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Institut d'Anesthésiologie des AM
Principal Investigators
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Carole R Ichai, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Service de Reanimation Medicochirurgical. CHU de Nice
Locations
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CHU de Nice
Nice, Alpes Maritimes, France
Countries
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References
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Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
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.
Other Identifiers
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NAC-CHUN1
Identifier Type: -
Identifier Source: org_study_id
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