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

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra (Other)

Overall Status

Completed

CT.gov ID

NCT01223326

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Jan 1, 2003

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

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 Names: Flumil
Placebo Comparator: Placebo Placebo	Drug: Saline Na Cl 0.9% infusion

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 Names:

Flumil

Placebo Comparator: Placebo

Placebo

Drug: Saline

Na Cl 0.9% infusion

Outcome Measures

Primary Outcome Measures

Laboratory results [24 hours]
Coagulation + cytolysis + cholestasis + lactic acid

Secondary Outcome Measures

Inflammation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clinica Universidad de Navarra, Universidad de Navarra

ClinicalTrials.gov Identifier:

NCT01223326

Other Study ID Numbers:

2003/NAC
PIUNA

First Posted:

Oct 19, 2010

Last Update Posted:

Jun 8, 2012

Last Verified:

Jun 1, 2012

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra

Acetylcysteine

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2012