Use of N-Acetylcysteine During Liver Procurement

NCT01394497 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2013-02-18

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    lead OTHER

Principal Investigators

  • Umberto Cillo, MD · Azienda Ospedaliera di Padova

  • Francesco D'Amico, MD · Azienda Ospedaliera di Padova

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394497 on ClinicalTrials.gov