Clinical trial NCT01866644: Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation
Official title: Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unspecified Complication of Liver Transplant
Keywords: Liver transplantation, n-acetylcysteine
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of primary graft dysfunction and primary failure
timeFrame: One week after treatment
Secondary outcomes:
measure: To assess the existence of side effects from the use of n-acetylcysteine on liver preservation solution usual.
timeFrame: One week after treatment
measure: Reduction of postoperative renal disfunction
timeFrame: One week after treatment
measure: Assess levels of glutathione stores achieved following administration of NAC
timeFrame: During harvesting
measure: Histological changes
timeFrame: During harvesting
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
affiliation: Hospital Universitario La Fe
name: Rafael Lopez Andujar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Fe
name: Concepcion Gómez i Gavara, MD
role: STUDY_CHAIR
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