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

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ClinicalTrials.gov Identifier: NCT01223326
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : June 8, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatectomy Reperfusion Injury Drug: Acetylcysteine (NAC) Drug: Saline Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Laboratory results [ Time Frame: 24 hours ]
    Coagulation + cytolysis + cholestasis + lactic acid


Secondary Outcome Measures :
  1. Inflammation [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01223326     History of Changes
Other Study ID Numbers: 2003/NAC
PIUNA ( Other Grant/Funding Number: Plan de Investigación de la Universidad de Navarra )
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012

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

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