Use of N-Acetylcysteine During Liver Procurement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Umberto Cillo, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier:
NCT01394497
First received: July 12, 2011
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Liver Failure
Liver Failure, Acute
Liver Diseases
Carcinoma, Hepatocellular
Liver Neoplasms
Drug: N-acetylcystein
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera di Padova:

Primary Outcome Measures:
  • Graft survival [ Time Frame: up to 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 140
Study Start Date: December 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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.
Other 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)
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394497

Locations
Italy
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Investigators
Study Director: Umberto Cillo, MD Azienda Ospedaliera di Padova
Principal Investigator: Francesco D'Amico, MD Azienda Ospedaliera di Padova
  More Information

Additional Information:
Publications:
Responsible Party: Prof. Umberto Cillo, Director of the Hepatobiliary Surgery and Liver Transplantation Unit, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT01394497     History of Changes
Other Study ID Numbers: 1635P
Study First Received: July 12, 2011
Last Updated: February 15, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera di Padova:
Liver Transplantation
Graft Survival
Graft Rejection
Primary Graft Dysfunction
Tissue and Organ Harvesting
Tissue and Organ Procurement
Tissue Donors
Cold Ischemia

Additional relevant MeSH terms:
Liver Diseases
Liver Failure
Liver Neoplasms
Carcinoma, Hepatocellular
Liver Failure, Acute
Digestive System Diseases
Hepatic Insufficiency
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 19, 2014