Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation

Instituto de Investigacion Sanitaria La Fe

Status and phase: Completed; Phase 3

Conditions: Unspecified Complication of Liver Transplant

Treatments: Drug: Saline; Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT01866644

NAC400

Details and patient eligibility

About

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).

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups, including a placebo group

N-acetylcysteine

Experimental group

Description:

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 ).

Treatment:

Drug: N-acetylcysteine

Saline

Placebo Comparator group

Description:

With usual technique

Treatment:

Drug: Saline