N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection
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|ClinicalTrials.gov Identifier: NCT01223326|
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : June 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hepatectomy Reperfusion Injury||Drug: Acetylcysteine (NAC) Drug: Saline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||December 2007|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223326
|Clinica Universidad de Navarra|
|Pamplona, Navarra, Spain, 31008|
|Study Director:||Pablo Monedero, M.D., Ph. D.||Clinica Universidad de Navarra|