Unspecified Complication of Liver Transplant
Conditions
Keywords
Liver transplantation, n-acetylcysteine
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.
Interventions
DRUGN-acetylcysteine
Bath transplanted liver with N-acetylcysteine
DRUGSaline
Bath saline transplanted liver
Sponsors
Instituto de Investigacion Sanitaria La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of primary graft dysfunction and primary failure | One week after treatment | Evaluate the incidence of primary graft dysfunction and primary failure in each group of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the existence of side effects from the use of n-acetylcysteine on liver preservation solution usual. | One week after treatment | — |
| Reduction of postoperative renal disfunction | One week after treatment | — |
| Assess levels of glutathione stores achieved following administration of NAC | 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 | During harvesting | Two biopsies which are going to be done in donor graft before and after reperfusion. |
Countries
Spain
Outcome results
None listed