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

U

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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