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Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation

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ClinicalTrials.gov Identifier: NCT01866644
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

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).

Condition or disease Intervention/treatment Phase
Unspecified Complication of Liver Transplant Drug: N-acetylcysteine Drug: Saline Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation
Actual Study Start Date : September 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 ).
Drug: N-acetylcysteine
Bath transplanted liver with N-acetylcysteine
Other Name: Flumil Solution injectable 300 Mg

Placebo Comparator: Saline
With usual technique
Drug: Saline
Bath saline transplanted liver
Other Name: It's not describe in a protocol




Primary Outcome Measures :
  1. The incidence of primary graft dysfunction and primary failure [ Time Frame: One week after treatment ]
    Evaluate the incidence of primary graft dysfunction and primary failure in each group of treatment.


Secondary Outcome Measures :
  1. To assess the existence of side effects from the use of n-acetylcysteine on liver preservation solution usual. [ Time Frame: One week after treatment ]
  2. Reduction of postoperative renal disfunction [ Time Frame: One week after treatment ]
  3. Assess levels of glutathione stores achieved following administration of NAC [ Time Frame: 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.

  4. Histological changes [ Time Frame: During harvesting ]
    Two biopsies which are going to be done in donor graft before and after reperfusion.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866644


Locations
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Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
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Principal Investigator: Rafael Lopez Andujar, PhD Hospital Universitario La Fe
Study Chair: Concepcion Gómez i Gavara, MD Hospital Universitario La Fe

Publications:

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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT01866644     History of Changes
Other Study ID Numbers: NAC400
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: June 2018

Keywords provided by Instituto de Investigacion Sanitaria La Fe:
Liver transplantation, n-acetylcysteine

Additional relevant MeSH terms:
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Pharmaceutical Solutions
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes