Use of N-Acetylcysteine During Liver Procurement
Liver Failure, Acute
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.|
- Graft survival [ Time Frame: up to 60 months ] [ Designated as safety issue: No ]
- Patient survival [ Time Frame: up to 60 months ] [ Designated as safety issue: No ]
- Primary graft dysfunction [ Time Frame: up to 60 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: NAC procurement protocol
The allocated organ, in addition to the standard procedure, was treated with a systemic NAC infusion before initiating the liver harvesting procedure, and a loco‑regional infusion into the portal vein before cross‑clamping.
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.
No Intervention: Standard procurement procedure
Allocated organ was treated according to the centre's standard procurement procedure: a modified double perfusion technique, where donor livers are gravity-perfused in situ via the aorta and portal vein with Celsior solution at 4 °C. After hepatectomy, donor livers were further perfused at the back‑table with Celsior solution and then stored in conventional bags containing the same solution at 4 °C until transplantation.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394497
|Azienda Ospedaliera di Padova|
|Padova, Italy, 35128|
|Study Director:||Umberto Cillo, MD||Azienda Ospedaliera di Padova|
|Principal Investigator:||Francesco D'Amico, MD||Azienda Ospedaliera di Padova|