Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation

August 9, 2018 updated by: Instituto de Investigacion Sanitaria La Fe
Evaluate the effectiveness of the administration produced antioxidant N-acetylcysteine (NAC), decreasing the incidence of primary graft dysfunction and primary failure. The degree of dysfunction will be monitored by the method of LIMON, metabonomics techniques and according to the latest published validation Liver Transplantation (16 943-949 2010), total billirrubina greater than 10 mg / dl, INR greater than 1.6 in the seventh postoperative day and alanine or aspartate aminotransferase greater than 2000 IU / L in the first seven days. Liver dysfunction is considered, the presence of a transaminase value> 2000 IU / L 1-7 postoperative day or BT> 10 mg / dl or INR> 1.6, both only in the 7th postoperative day (Olthoff et al Liver Transplantation 16,943 -949 2010).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The reason of this study is to evaluate the efficacy of the use of n-acetylcysteine in liver transplant, by administering it in the perfusion liquid, at the time of extraction of the liver of the donor to improve the damage caused by ischemia / reperfusion. The dose is 400 mg in the portal perfusion liquid.

The study included all considered valid and perfused livers. Patients are randomized to contain no drug or n-acetylcysteine by randomization. Then analyzed using blood tests and in the receiver and daily during the first seven days post-transplant hepatic dysfunction parameters, in order to objectify if liver function improves after administration of the antioxidant (n-acetylcysteine ). Safety assessments were performed with intraoperative monitoring anesthetic depth, postoperative parameters of liver and kidney function and graft pathologic examination after perfusion.

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All grafts perfused by extraction for liver transplantation.

Exclusion Criteria:

  • < 18 years
  • Allergy to NAC
  • Grafts considered invalid for liver transplantation after perfusion
  • Hepatitis fulminant
  • Retransplantation
  • Split
  • > 10 hours of cold ischemia
  • Patients with asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N-acetylcysteine
At portal level, a cannula is inserted with the usual technique of infusion of 3000 ml of preservation fluid to free fall as containing or not scrambling inserted by the NAC scrub nurse then (400 mg of N-acetylcysteine at 10%, 4 ml ).
Drug: N-acetylcysteine
Bath transplanted liver with N-acetylcysteine
Other Names:
  • Flumil Solution injectable 300 Mg
Placebo Comparator: Saline
With usual technique
Drug: Saline
Bath saline transplanted liver
Other Names:
  • It's not describe in a protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of primary graft dysfunction and primary failure
Time Frame: One week after treatment
Evaluate the incidence of primary graft dysfunction and primary failure in each group of treatment.
One week after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the existence of side effects from the use of n-acetylcysteine on liver preservation solution usual.
Time Frame: One week after treatment
One week after treatment
Reduction of postoperative renal disfunction
Time Frame: One week after treatment
One week after treatment
Assess levels of glutathione stores achieved following administration of NAC
Time Frame: During harvesting
During the harvesting and implantation in the recipient liver three liver biopsies will be performed which will be assessed by determining metabonomics metabolites of the transsulfuration pathway and GSH levels.
During harvesting
Histological changes
Time Frame: During harvesting
Two biopsies which are going to be done in donor graft before and after reperfusion.
During harvesting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Principal Investigator: Rafael Lopez Andujar, PhD, Hospital Universitario La Fe
  • Study Chair: Concepcion Gómez i Gavara, MD, Hospital Universitario La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

May 27, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAC400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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