N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection

Phase 4

Completed

• Conditions: Hepatectomy; Reperfusion Injury
• Interventions: Drug: Acetylcysteine (NAC); Drug: Saline

• Registration Number: NCT01223326
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

Study hypothesis: N-acetylcysteine (NAC) can reduce ischemia/reperfusion injury in liver resection performed under ischemic preconditioning and intermittent portal triad clamping.

Detailed Description

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 Timeline

• Study Start: 2003-01
• Primary Completion: 2007-10
• Study Completion: 2007-12
• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Hepatectomy

Exclusion Criteria

• ASA 4
• Cirrhosis
• Creatinine > 1.2 mg/dL
• Associate surgery (pancreatic or splenectomy)
• Intraoperative bleeding > 2 L.
• Active infection of inflammatory disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine	Acetylcysteine (NAC)	Intravenous N-acetylcysteine
Placebo	Saline	Placebo

Primary Outcome Measures

Name	Time	Method
Laboratory results	24 hours	Coagulation + cytolysis + cholestasis + lactic acid

Secondary Outcome Measures

Name	Time	Method
Inflammation	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.

Trial Locations

Locations (1)

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain