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

NCT ID: NCT01223326

Last Updated: 2012-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2007-12-31

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.

Conditions

Hepatectomy; Reperfusion Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

N-acetylcysteine

Intravenous N-acetylcysteine

Group Type: EXPERIMENTAL

Acetylcysteine (NAC)

Intervention Type: DRUG

NAC 150 mg/Kg; and infusion of 50 mg/kg, from 30 minutes before the ischemia up to 60 minutes later to the reperfusion

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Na Cl 0.9% infusion

Interventions

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

Intervention Type: DRUG

Saline

Na Cl 0.9% infusion

Intervention Type: DRUG

Other Intervention Names

Flumil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo Monedero, M.D., Ph. D.

Role: STUDY_DIRECTOR

Clinica Universidad de Navarra

Locations

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

PIUNA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2003/NAC

Identifier Type: -

Identifier Source: org_study_id