Carcinoma, Hepatocellular, Liver Diseases, Liver Failure, Liver Failure, Acute, Liver Neoplasms
Conditions
Keywords
Liver Transplantation, Graft Survival, Graft Rejection, Primary Graft Dysfunction, Tissue and Organ Harvesting, Tissue and Organ Procurement, Tissue Donors, Cold Ischemia
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.
Interventions
DRUGN-acetylcystein
15 min systemic NAC infusion of the donor (30 mg/kg, maximum dose 3000 mg) diluted into 500 ml 5 % glucose solution, 30 min before initiating the liver harvesting procedure, and a loco-regional infusion (150 mg/kg of estimated liver weight, maximum dose 300 mg) into the portal vein 5 min before cross-clamping.
Sponsors
Azienda Ospedaliera di Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft survival | up to 60 months |
Secondary
| Measure | Time frame |
|---|---|
| Patient survival | up to 60 months |
| Primary graft dysfunction | up to 60 months |
Countries
Italy
Outcome results
None listed