Completed

NCT Number: NCT01866644

Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation

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).

Completed

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Key information

Conditions

Unspecified Complication of Liver Transplant

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

N-acetylcysteine

Drug

Bath transplanted liver with N-acetylcysteine

Other names: Flumil Solution injectable 300 Mg

Saline

Drug

Bath saline transplanted liver

Other names: It's not describe in a protocol

Primary outcomes

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.

Secondary outcomes

To assess the existence of side effects from the use of n-acetylcysteine on liver preservation solution usual.

Time frame: One week after treatment
Reduction of postoperative renal disfunction

Time frame: 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.
Histological changes

Time frame: During harvesting

Two biopsies which are going to be done in donor graft before and after reperfusion.

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: May 31, 2013
Registry last updated: Aug 13, 2018

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.