Use of N-Acetylcysteine During Liver Procurement

University of Padua

Status and phase: Completed; Phase 2

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

Treatments: Drug: N-acetylcystein

Study type: Interventional

Funder types: Other

Identifiers

NCT01394497

1635P

Details and patient eligibility

About

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).

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

NAC procurement protocol

Experimental group

Description:

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.

Treatment:

Drug: N-acetylcystein

Standard procurement procedure

No Intervention group

Description:

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.