Liver FailurePhase 2NCT01394497
Use of N-Acetylcysteine During Liver Procurement
A Phase 2 study testing N-acetylcystein in people with Liver Failure and Liver Failure, Acute, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Liver Failure, Acute, Liver Diseases
- What is being tested?
- N-acetylcystein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2006to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consecutive subjects with chronic liver disease undergoing first Liver Transplantation receiving deceased donor livers
Who cannot join
- recipients with acute liver disease;
- paediatric patients or adult patients receiving a liver from a paediatric donor;
- patients undergoing multiple-organ transplantation;
- patients undergoing re-transplantation of the Liver;
- patients undergoing living donor Liver Transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.
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).
Read the 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
- Liver Failure, Liver Failure, Acute, Liver Diseases, Carcinoma, Hepatocellular, Liver Neoplasms
- Being tested
- N-acetylcystein
- Keywords
- Liver Transplantation, Graft Survival, Graft Rejection, Primary Graft Dysfunction, Tissue and Organ Harvesting, Tissue and Organ Procurement, Tissue Donors, Cold Ischemia
- Medical subject headings
- Liver Failure, Liver Failure, Acute, Liver Diseases, Carcinoma, Hepatocellular, Liver Neoplasms, Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteinDrug
Also called Fluimucil (Zambon, Italy), ACC (Hexal AG), Acemuc (Betapharm, Germany), Acetyst (Ristert, Germany)
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.
| Study group | Role | What they receive |
|---|---|---|
| NAC procurement protocol | Experimental | 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. Receives: Drug: N-acetylcystein |
| Standard procurement procedure | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft survival
Measured: up to 60 months
Secondary outcomes (2)
Patient survival
Measured: up to 60 months
Primary graft dysfunction
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startDec 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Umberto Cillo, Azienda Ospedaliera di Padova
- Investigators
- Umberto Cillo, MD, Study director, Azienda Ospedaliera di PadovaFrancesco D'Amico, MD, Principal investigator, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394497
- Sponsor's protocol ID
- 1635P
- Status last verified
- Feb 2013
- First submitted
- 12 Jul 2011
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
D'Amico F, Vitale A, Gringeri E, Valmasoni M, Carraro A, Brolese A, Zanus G, Neri D, Boccagni P, Violi P, Pauletto A, D'Amico FE, D'Amico DF, Cillo U. SYSTEMIC AND LOCO-REGIONAL INFUSION OF N-ACETILCISTEINA DURING LIVER PROCUREMENT: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY (Abstract# 488), The International Liver Transplantation Society: 14th Annual International Congress, July 9-12, 2008, Paris, France. Liver Transplantation, 14: S1-S269. doi: 10.1002/lt.21569
D'Amico F, Vitale A, Piovan D, Bertacco A, Ramirez Morales R, Chiara Frigo A, Bassi D, Bonsignore P, Gringeri E, Valmasoni M, Garbo G, Lodo E, D'Amico FE, Scopelliti M, Carraro A, Gambato M, Brolese A, Zanus G, Neri D, Cillo U. Use of N-acetylcysteine during liver procurement: a prospective randomized controlled study. Liver Transpl. 2013 Feb;19(2):135-44. doi: 10.1002/lt.23527. Epub 2012 Sep 26.
PubMed 22859317
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.
- ClinicalTrials.gov ID
- NCT01394497
- Acronym / sponsor ID
- 1635P
- Conditions
- Liver Failure, Liver Failure, Acute, Liver Diseases, Carcinoma, Hepatocellular, Liver Neoplasms
- Keywords
- Liver Transplantation, Graft Survival, Graft Rejection, Primary Graft Dysfunction, Tissue and Organ Harvesting, Tissue and Organ Procurement, Tissue Donors, Cold Ischemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC procurement protocol | Experimental | Drug: N-acetylcysteinThe 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. |
| Standard procurement procedure | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive subjects with chronic liver disease undergoing first Liver Transplantation receiving deceased donor livers
Key exclusion criteria (5 listed)
- recipients with acute liver disease;
- paediatric patients or adult patients receiving a liver from a paediatric donor;
- patients undergoing multiple-organ transplantation;
- patients undergoing re-transplantation of the Liver;
- patients undergoing living donor Liver Transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteinAlso: Fluimucil (Zambon, Italy), ACC (Hexal AG), Acemuc (Betapharm, Germany), Acetyst (Ristert, Germany)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. | Drug | NAC procurement protocol |
Primary outcome
Graft survival
Time frame: up to 60 months
2 secondary outcomes
Patient survival
Time frame: up to 60 months
Primary graft dysfunction
Time frame: up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
- Results publicationD'Amico F, Vitale A, Gringeri E, Valmasoni M, Carraro A, Brolese A, Zanus G, Neri D, Boccagni P, Violi P, Pauletto A, D'Amico FE, D'Amico DF, Cillo U. SYSTEMIC AND LOCO-REGIONAL INFUSION OF N-ACETILCISTEINA DURING LIVER PROCUREMENT: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY (Abstract# 488), The International Liver Transplantation Society: 14th Annual International Congress, July 9-12, 2008, Paris, France. Liver Transplantation, 14: S1-S269. doi: 10.1002/lt.21569
- Results publication: PubMed 22859317D'Amico F, Vitale A, Piovan D, Bertacco A, Ramirez Morales R, Chiara Frigo A, Bassi D, Bonsignore P, Gringeri E, Valmasoni M, Garbo G, Lodo E, D'Amico FE, Scopelliti M, Carraro A, Gambato M, Brolese A, Zanus G, Neri D, Cillo U. Use of N-acetylcysteine during liver procurement: a prospective randomized controlled study. Liver Transpl. 2013 Feb;19(2):135-44. doi: 10.1002/lt.23527. Epub 2012 Sep 26.
- Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)Link provided by the sponsor.
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Liver Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umberto Cillo, MD study director
Azienda Ospedaliera di Padova
Francesco D'Amico, MD principal investigator
Azienda Ospedaliera di Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcystein in people with Liver Failure and Liver Failure, Acute, run by Azienda Ospedaliera di Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft survival (time frame: up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01394497, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.