Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.
18 Years
N/A
Both
Liver Failure, Liver Failure, Acute, Liver Diseases, Carcinoma, Hepatocellular, Liver Neoplasms
Trial Information
Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Outcome Measure:
Graft survival
Outcome Time Frame:
up to 60 months
Safety Issue:
No
Principal Investigator
Umberto Cillo, MD
Investigator Role:
Study Director
Investigator Affiliation:
Azienda Ospedaliera di Padova
Authority:
Italy: Ethics Committee
Study ID:
1635P
NCT ID:
NCT01394497
Start Date:
December 2006
Completion Date:
July 2009
Related Keywords:
- Liver Failure
- Liver Failure, Acute
- Liver Diseases
- Carcinoma, Hepatocellular
- Liver Neoplasms
- Liver Transplantation
- Graft Survival
- Graft Rejection
- Primary Graft Dysfunction
- Tissue and Organ Harvesting
- Tissue and Organ Procurement
- Tissue Donors
- Cold Ischemia
- Neoplasms
- Carcinoma
- Liver Diseases
- Liver Neoplasms
- Liver Failure
- Liver Failure, Acute
- Carcinoma, Hepatocellular
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