Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation

NCT ID: NCT01866644

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-06-30

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.

Conditions

Unspecified Complication of Liver Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

N-acetylcysteine

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 ).

Group Type: EXPERIMENTAL

N-acetylcysteine

Intervention Type: DRUG

Bath transplanted liver with N-acetylcysteine

Saline

With usual technique

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Bath saline transplanted liver

Interventions

N-acetylcysteine

Bath transplanted liver with N-acetylcysteine

Intervention Type: DRUG

Saline

Bath saline transplanted liver

Intervention Type: DRUG

Other Intervention Names

Flumil Solution injectable 300 Mg; It's not describe in a protocol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Lopez Andujar, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Fe

Concepcion Gómez i Gavara, MD

Role: STUDY_CHAIR

Hospital Universitario La Fe

Locations

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Countries

Spain

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Other Identifiers

NAC400

Identifier Type: -

Identifier Source: org_study_id