Clinical Trial: Use of N-Acetylcysteine During Liver Procurement
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.
Brief Summary: Randomized prospective study on the impact on the post-LT outcome by the infusion of N-acetylcysteine (NAC) during the liver procurement procedure, as an anti-oxidant agent to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT).
Detailed Summary:
Anti-oxidant agents have the potential to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT). In this randomized prospective study, we seek to study the impact on the post-LT outcome of the infusion of N-acetylcysteine (NAC) during the liver procurement procedure.
Potential grafts, assigned to adult candidates with chronic liver disease enlisted for first LT, will randomly be included in a one‑to‑one ratio with a sequential closed envelope single-blinded assignation procedure to either the NAC protocol or in the standard procedure (without NAC).
The NAC protocol comprises: a systemic NAC infusion (30 mg/kg) one hour before the beginning of liver procurement; a loco-regional NAC infusion (300 mg through the portal vein) just before cross‑clamping.
Sponsor: Azienda Ospedaliera di Padova
Current Primary Outcome: Graft survival [ Time Frame: up to 60 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Patient survival [ Time Frame: up to 60 months ]
- Primary graft dysfunction [ Time Frame: up to 60 months ]
Original Secondary Outcome: Same as current
Information By: Azienda Ospedaliera di Padova
Dates:
Date Received: July 12, 2011
Date Started: December 2006
Date Completion:
Last Updated: February 15, 2013
Last Verified: February 2013
