Clinical trial NCT01394497: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Failure
Liver Failure, Acute
Liver Diseases
Carcinoma, Hepatocellular
Liver Neoplasms
Keywords: Liver Transplantation
Graft Survival
Graft Rejection
Primary Graft Dysfunction
Tissue and Organ Harvesting
Tissue and Organ Procurement
Tissue Donors
Cold Ischemia
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* all consecutive subjects with chronic liver disease undergoing first Liver Transplantation receiving deceased donor livers

Exclusion Criteria:

* recipients with acute liver disease;
* paediatric patients or adult patients receiving a liver from a paediatric donor;
* patients undergoing multiple-organ transplantation;
* patients undergoing re-transplantation of the Liver;
* patients undergoing living donor Liver Transplantation

Primary outcomes:
measure: Graft survival
timeFrame: up to 60 months
Secondary outcomes:
measure: Patient survival
timeFrame: up to 60 months
measure: Primary graft dysfunction
timeFrame: up to 60 months
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
Study officials:
affiliation: Azienda Ospedaliera di Padova
name: Umberto Cillo, MD
role: STUDY_DIRECTOR
affiliation: Azienda Ospedaliera di Padova
name: Francesco D'Amico, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Amico F, Vitale A, Gringeri E, Valmasoni M, Carraro A, Brolese A, Zanus G, Neri D, Boccagni P, Violi P, Pauletto A, D'Amico FE, D'Amico DF, Cillo U. SYSTEMIC AND LOCO-REGIONAL INFUSION OF N-ACETILCISTEINA DURING LIVER PROCUREMENT: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY (Abstract# 488), The International Liver Transplantation Society: 14th Annual International Congress, July 9-12, 2008, Paris, France. Liver Transplantation, 14: S1-S269. doi: 10.1002/lt.21569
citation: D'Amico F, Vitale A, Piovan D, Bertacco A, Ramirez Morales R, Chiara Frigo A, Bassi D, Bonsignore P, Gringeri E, Valmasoni M, Garbo G, Lodo E, D'Amico FE, Scopelliti M, Carraro A, Gambato M, Brolese A, Zanus G, Neri D, Cillo U. Use of N-acetylcysteine during liver procurement: a prospective randomized controlled study. Liver Transpl. 2013 Feb;19(2):135-44. doi: 10.1002/lt.23527. Epub 2012 Sep 26.