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NCT Number: NCT01394497

Use of N-Acetylcysteine During Liver Procurement

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).

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Key information

Conditions

Liver Failure Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Hepatic Insufficiency Liver Diseases Liver Failure, Acute Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Primary Graft Dysfunction Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Azienda Ospedaliera di Padova

Padova, 35128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcystein

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.

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)

Primary outcomes

  1. Graft survival

    Time frame: up to 60 months

Secondary outcomes

  1. Patient survival

    Time frame: up to 60 months

  2. Primary graft dysfunction

    Time frame: up to 60 months

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Registry information

Official study title

Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jul 14, 2011
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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