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

University of Navarra

Status and phase: Completed; Phase 4

Conditions: Hepatectomy; Reperfusion Injury

Treatments: Drug: Saline; Drug: Acetylcysteine (NAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT01223326

2003/NAC

PIUNA (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

N-acetylcysteine

Experimental group

Description:

Intravenous N-acetylcysteine

Treatment:

Drug: Acetylcysteine (NAC)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Saline