N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection
|Hepatectomy Reperfusion Injury||Drug: Acetylcysteine (NAC) Drug: Saline||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Randomized Controlled Trial of N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection Performed Under Ischemic Preconditioning and Intermittent Portal Triad Clamping|
- Laboratory results [ Time Frame: 24 hours ]Coagulation + cytolysis + cholestasis + lactic acid
- Inflammation [ Time Frame: 24 hours ]Cytokines, adhesion molecules (P-selectin and ICAM-1) and nuclear factor kappaB (NF-kappaB). Circulating neutrophils/platelets. Oxidative stress of neutrophils and apoptosis.
|Study Start Date:||January 2003|
|Study Completion Date:||December 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Drug: Acetylcysteine (NAC)
NAC 150 mg/Kg; and infusion of 50 mg/kg, from 30 minutes before the ischemia up to 60 minutes later to the reperfusion
Other Name: Flumil
Placebo Comparator: Placebo
Na Cl 0.9% infusion
One of the most important factors in the pathophysiology of liver dysfunction after hepatic surgery is the cellular damage derived from the interruption of blood flood with reperfusion of the organ. N-acetylcysteine (NAC) has proved beneficial in several conditions involving oxidative damage. This study investigates the effects of NAC to reduce ischemia/reperfusion injury in liver resection performed under ischemic preconditioning and intermittent portal triad clamping.
Methods: 46 ASA II-III patients scheduled to undergo liver resection where randomised to receive NAC (initial dose: 150 mg/Kg; and infusion of 50 mg/kg, from 30 minutes before the ischemia up to 60 minutes later to the reperfusion) or placebo in a phase IV clinical trial. Blood, hepatic and urinary markers were obtained at basal status and 1, 3 and 24 h post final reperfusion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223326
|Clinica Universidad de Navarra|
|Pamplona, Navarra, Spain, 31008|
|Study Director:||Pablo Monedero, M.D., Ph. D.||Clinica Universidad de Navarra|