Use of N-Acetylcysteine During Liver Procurement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.

Conditions
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Liver Failure, Liver Failure, Acute, Liver Diseases, Carcinoma, Hepatocellular, Liver Neoplasms

Intervention / Treatment
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* Drug: N-acetylcystein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAC procurement protocol<br>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. | Drug: N-acetylcystein<br>* 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.<br>* Other names: Trebon N (Uni-pharma);|
| No Intervention: Standard procurement procedure<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival |  | up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival |  | up to 60 months | 
| Primary graft dysfunction |  | up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Transplantation, Graft Survival, Graft Rejection, Primary Graft Dysfunction, Tissue and Organ Harvesting, Tissue and Organ Procurement, Tissue Donors, Cold Ischemia