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Brief Title: Use of N-Acetylcysteine During Liver Procurement
Official Title: Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.
Study ID: NCT01394497
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 Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Azienda Ospedaliera di Padova, Padova, , Italy
Name: Umberto Cillo, MD
Affiliation: Azienda Ospedaliera di Padova
Role: STUDY_DIRECTOR
Name: Francesco D'Amico, MD
Affiliation: Azienda Ospedaliera di Padova
Role: PRINCIPAL_INVESTIGATOR