Trials / Completed
CompletedNCT01394497
Use of N-Acetylcysteine During Liver Procurement
Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Azienda Ospedaliera di Padova · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Randomized prospective study on the impact on the post-LT outcome by the infusion of N-acetylcysteine (NAC) during the liver procurement procedure, as an anti-oxidant agent to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | N-acetylcystein | 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. |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2009-07-01
- Completion
- 2009-07-01
- First posted
- 2011-07-14
- Last updated
- 2013-02-18
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01394497. Inclusion in this directory is not an endorsement.