Use of N-Acetylcysteine During Liver Procurement

Phase 2

Completed

• Conditions: Liver Failure; Liver Failure, Acute; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Interventions: Drug: N-acetylcystein

• Registration Number: NCT01394497
• Lead Sponsor: Azienda Ospedaliera di Padova

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.

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-15
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAC procurement protocol	N-acetylcystein	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.

Primary Outcome Measures

Name	Time	Method
Graft survival	up to 60 months

Secondary Outcome Measures

Name	Time	Method
Patient survival	up to 60 months
Primary graft dysfunction	up to 60 months

Trial Locations

Locations (1)

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy