Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe
• Treatments: Acetylcysteine; N-monoacetylcystine; Pharmaceutical Solutions

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