Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01866644|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Complication of Liver Transplant||Drug: N-acetylcysteine Drug: Saline||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 ).
Bath transplanted liver with N-acetylcysteine
Other Name: Flumil Solution injectable 300 Mg
Placebo Comparator: Saline
With usual technique
Bath saline transplanted liver
Other Name: It's not describe in a protocol
- 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.
- 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 ]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.
- Histological changes [ Time Frame: During harvesting ]Two biopsies which are going to be done in donor graft before and after reperfusion.
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
|Hospital Universitari i Politècnic La Fe|
|Valencia, Spain, 46026|
|Principal Investigator:||Rafael Lopez Andujar, PhD||Hospital Universitario La Fe|
|Study Chair:||Concepcion Gómez i Gavara, MD||Hospital Universitario La Fe|