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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01223326
First received: October 15, 2010
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Hepatectomy
Reperfusion Injury
Drug: Acetylcysteine (NAC)
Drug: Saline
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Laboratory results [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Coagulation + cytolysis + cholestasis + lactic acid


Secondary Outcome Measures:
  • Inflammation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Cytokines, adhesion molecules (P-selectin and ICAM-1) and nuclear factor kappaB (NF-kappaB). Circulating neutrophils/platelets. Oxidative stress of neutrophils and apoptosis.


Enrollment: 46
Study Start Date: January 2003
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-acetylcysteine
Intravenous N-acetylcysteine
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
Placebo
Drug: Saline
Na Cl 0.9% infusion
Other Name: Saline

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223326

Locations
Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Study Director: Pablo Monedero, M.D., Ph. D. Clinica Universidad de Navarra
  More Information

No publications provided

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01223326     History of Changes
Other Study ID Numbers: 2003/NAC, PIUNA
Study First Received: October 15, 2010
Last Updated: June 7, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Acetylcysteine

Additional relevant MeSH terms:
Reperfusion Injury
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications
Vascular Diseases
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014