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.

Abstract

Background: Antioxidant donor pretreatment is one of the pharmacologic strategy proposed to prevent renal ischemia-reperfusion injuries and delayed graft function (DGF). The aim of the study was to investigate whether a donor pretreatment with N-acetylcysteine (NAC) reduces the incidence of DGF in adult human kidney transplant recipients.

Methods: In this randomized, open-label, monocenter trial, 160 deceased heart-beating donors were allowed to perform 236 renal transplantations from September 2005 to December 2010. Donors were randomized to receive, in a single-blind controlled fashion, 600 mg of intravenous NAC 1 hr before and 2 hr after cerebral angiography performed to confirm brain death. Primary endpoint was DGF defined by the need for at least one dialysis session within the first week or a serum creatinine level greater than 200 μmol/L at day 7 after kidney transplantation.

Results: The incidence of DGF was similar between donors pretreated with or without NAC (39/118; 33% vs. 30/118; 25.4%; P = 0.19). Requirement for at least one dialysis session was not different between the NAC and No NAC groups (17/118; 14.4% vs. 14/118; 11.8%, P = 0.56). The two groups had comparable serum creatinine levels, estimated glomerular filtration rates, and daily urine output at days 1, 7, 15, and 30 after kidney transplantation as well as at hospital discharge. No difference in recipient mortality nor in 1-year kidney graft survival was observed.

Conclusion: Donor pretreatment with NAC does not improve delayed graft function after kidney transplantation.

Trial registration: ClinicalTrials.gov NCT00998972.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acetylcysteine / administration & dosage*
  • Administration, Intravenous
  • Adult
  • Allografts
  • Antioxidants / administration & dosage*
  • Biomarkers / blood
  • Brain Death / diagnosis
  • Cerebral Angiography
  • Creatinine / blood
  • Delayed Graft Function / diagnosis
  • Delayed Graft Function / etiology
  • Delayed Graft Function / mortality
  • Delayed Graft Function / physiopathology
  • Delayed Graft Function / prevention & control*
  • Drug Administration Schedule
  • Female
  • France
  • Glomerular Filtration Rate / drug effects
  • Graft Survival / drug effects
  • Humans
  • Kidney Transplantation / adverse effects
  • Kidney Transplantation / methods*
  • Kidney Transplantation / mortality
  • Male
  • Middle Aged
  • Prospective Studies
  • Renal Dialysis
  • Single-Blind Method
  • Time Factors
  • Tissue Donors*
  • Treatment Outcome
  • Up-Regulation
  • Urination / drug effects

Substances

  • Antioxidants
  • Biomarkers
  • Creatinine
  • Acetylcysteine

Associated data

  • ClinicalTrials.gov/NCT00998972