Use of N-Acetylcysteine During Liver Procurement
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|ClinicalTrials.gov Identifier: NCT01394497|
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : February 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Liver Failure Liver Failure, Acute Liver Diseases Carcinoma, Hepatocellular Liver Neoplasms||Drug: N-acetylcystein||Phase 2|
Anti-oxidant agents have the potential to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT). In this randomized prospective study, we seek to study the impact on the post-LT outcome of the infusion of N-acetylcysteine (NAC) during the liver procurement procedure.
Potential grafts, assigned to adult candidates with chronic liver disease enlisted for first LT, will randomly be included in a one‑to‑one ratio with a sequential closed envelope single-blinded assignation procedure to either the NAC protocol or in the standard procedure (without NAC).
The NAC protocol comprises: a systemic NAC infusion (30 mg/kg) one hour before the beginning of liver procurement; a loco-regional NAC infusion (300 mg through the portal vein) just before cross‑clamping.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Experimental: NAC procurement protocol
The allocated organ, in addition to the standard procedure, was treated with a systemic NAC infusion before initiating the liver harvesting procedure, and a loco‑regional infusion into the portal vein before cross‑clamping.
15 min systemic NAC infusion of the donor (30 mg/kg, maximum dose 3000 mg) diluted into 500 ml 5 % glucose solution, 30 min before initiating the liver harvesting procedure, and a loco‑regional infusion (150 mg/kg of estimated liver weight, maximum dose 300 mg) into the portal vein 5 min before cross‑clamping.
No Intervention: Standard procurement procedure
Allocated organ was treated according to the centre's standard procurement procedure: a modified double perfusion technique, where donor livers are gravity-perfused in situ via the aorta and portal vein with Celsior solution at 4 °C. After hepatectomy, donor livers were further perfused at the back‑table with Celsior solution and then stored in conventional bags containing the same solution at 4 °C until transplantation.
- Graft survival [ Time Frame: up to 60 months ]
- Patient survival [ Time Frame: up to 60 months ]
- Primary graft dysfunction [ Time Frame: up to 60 months ]
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): NCT01394497
|Azienda Ospedaliera di Padova|
|Padova, Italy, 35128|
|Study Director:||Umberto Cillo, MD||Azienda Ospedaliera di Padova|
|Principal Investigator:||Francesco D'Amico, MD||Azienda Ospedaliera di Padova|