Use of N-Acetylcysteine During Liver Procurement

NCT ID: NCT01394497

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

N-acetylcystein

Intervention Type: DRUG

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

N-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.

Intervention Type: DRUG

Other Intervention Names

Fluimucil (Zambon, Italy); ACC (Hexal AG); Acemuc (Betapharm, Germany); Acetyst (Ristert, Germany); Acetadote (Cumberland Pharmaceuticals); Asist (Bilim Pharmaceuticals, Turkey); Brunac eyedrops (Bruschettini, Italy); Fluimukan (Lek, Slovenia); Flumil (Pharmazam, Spain); Lysox (Menarini); Mucinac (Cipla, India); Mucohelp (Neiss Labs, India); Mucolysin (Sandoz); Mucomelt (Venus Remedies, India); MUCOMIX (Samarth Life Sciences, India); Mucomyst (Bristol-Myers Squibb); Nytex (Pharos,Indonesia); Parvolex (GSK); PharmaNAC (BioAdvantex Pharma Inc., North America); Rheunac (Tree Of Life, Israel); Solmucaïne (IBSA, Switzerland); Trebon N (Uni-pharma)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera di Padova

OTHER

Sponsor Role: lead

Responsible Party

Prof. Umberto Cillo

Director of the Hepatobiliary Surgery and Liver Transplantation Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Umberto Cillo, MD

Role: STUDY_DIRECTOR

Azienda Ospedaliera di Padova

Francesco D'Amico, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera di Padova

Locations

Azienda Ospedaliera di Padova

Padua, Padova, Italy

Countries

Italy

References

D'Amico F, Vitale A, Gringeri E, Valmasoni M, Carraro A, Brolese A, Zanus G, Neri D, Boccagni P, Violi P, Pauletto A, D'Amico FE, D'Amico DF, Cillo U. SYSTEMIC AND LOCO-REGIONAL INFUSION OF N-ACETILCISTEINA DURING LIVER PROCUREMENT: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY (Abstract# 488), The International Liver Transplantation Society: 14th Annual International Congress, July 9-12, 2008, Paris, France. Liver Transplantation, 14: S1-S269. doi: 10.1002/lt.21569

Reference Type: RESULT

D'Amico F, Vitale A, Piovan D, Bertacco A, Ramirez Morales R, Chiara Frigo A, Bassi D, Bonsignore P, Gringeri E, Valmasoni M, Garbo G, Lodo E, D'Amico FE, Scopelliti M, Carraro A, Gambato M, Brolese A, Zanus G, Neri D, Cillo U. Use of N-acetylcysteine during liver procurement: a prospective randomized controlled study. Liver Transpl. 2013 Feb;19(2):135-44. doi: 10.1002/lt.23527. Epub 2012 Sep 26.

Reference Type: RESULT

PMID: 22859317 (View on PubMed)

Related Links

http://www.fegatochirurgia.com/

Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)

Other Identifiers

1635P

Identifier Type: -

Identifier Source: org_study_id