This trial is active, not recruiting.

Condition unspecified complication of liver transplant
Treatments n-acetylcysteine, saline
Phase phase 3
Sponsor Instituto de Investigacion Sanitaria La Fe
Start date September 2011
End date June 2016
Trial size 214 participants
Trial identifier NCT01866644, NAC400


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
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 ).
n-acetylcysteine Flumil Solution injectable 300 Mg
Bath transplanted liver with N-acetylcysteine
(Placebo Comparator)
With usual technique
saline It's not describe in a protocol
Bath saline transplanted liver

Primary Outcomes

The incidence of primary graft dysfunction and primary failure
time frame: One week after 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
Histological changes
time frame: During harvesting

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

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

Additional Information

Official title Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation
Principal investigator Rafael Lopez Andujar, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Instituto de Investigacion Sanitaria La Fe.