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Use of N-Acetylcysteine During Liver Procurement

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ClinicalTrials.gov Identifier: NCT01394497
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : February 18, 2013
Sponsor:
Information provided by (Responsible Party):
Prof. Umberto Cillo, 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).

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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.
Study Start Date : December 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Graft survival [ Time Frame: up to 60 months ]

Secondary Outcome Measures :
  1. Patient survival [ Time Frame: up to 60 months ]
  2. Primary graft dysfunction [ Time Frame: up to 60 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394497


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

Additional Information:
Publications of Results:
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

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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
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013
Keywords provided by Prof. Umberto Cillo, 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:
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Carcinoma, Hepatocellular
Liver Neoplasms
Liver Diseases
Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Liver Extracts
Hematinics