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
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