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

Primary Purpose

Hepatectomy, Reperfusion Injury

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Acetylcysteine (NAC)
Saline
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatectomy focused on measuring Acetylcysteine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica Universidad de Navarra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-acetylcysteine

Placebo

Arm Description

Intravenous N-acetylcysteine

Placebo

Outcomes

Primary Outcome Measures

Laboratory results
Coagulation + cytolysis + cholestasis + lactic acid

Secondary Outcome Measures

Inflammation
Cytokines, adhesion molecules (P-selectin and ICAM-1) and nuclear factor kappaB (NF-kappaB). Circulating neutrophils/platelets. Oxidative stress of neutrophils and apoptosis.

Full Information

First Posted
October 15, 2010
Last Updated
June 7, 2012
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT01223326
Brief Title
N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatectomy, Reperfusion Injury
Keywords
Acetylcysteine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
Intravenous N-acetylcysteine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Acetylcysteine (NAC)
Other Intervention Name(s)
Flumil
Intervention Description
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
Intervention Name(s)
Saline
Intervention Description
Na Cl 0.9% infusion
Primary Outcome Measure Information:
Title
Laboratory results
Description
Coagulation + cytolysis + cholestasis + lactic acid
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Inflammation
Description
Cytokines, adhesion molecules (P-selectin and ICAM-1) and nuclear factor kappaB (NF-kappaB). Circulating neutrophils/platelets. Oxidative stress of neutrophils and apoptosis.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Monedero, M.D., Ph. D.
Organizational Affiliation
Clinica Universidad de Navarra
Official's Role
Study Director
Facility Information:
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

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

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