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

Information source: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatectomy; Reperfusion Injury

Intervention: Acetylcysteine (NAC) (Drug); Saline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Clinica Universidad de Navarra, Universidad de Navarra

Official(s) and/or principal investigator(s):
Pablo Monedero, M.D., Ph. D., Study Director, Affiliation: Clinica Universidad de Navarra

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Laboratory results

Secondary outcome: Inflammation

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Clinica Universidad de Navarra, Pamplona, Navarra 31008, Spain
Additional Information

Starting date: January 2003
Last updated: June 7, 2012

Page last updated: August 23, 2015

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