Liver Transplant AbscessNCT03064685
Risk Factors and Outcomes of Pyogenic Liver Abscess in Adult Liver Recipients: A Match Case Control Study
An observational study of Liver Transplant Abscess, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Objective: the aim of this study is to identify risk factors associated with the development of pyogenic liver abscesses (PLA) in adult liver recipients (ALR) and to describe the experience of the Hospital Italiano de Buenos Aires (HIBA) in the diagnosis and therapeutic management of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Abscess
- How many people
- 126 participants
- Where
- 1 siteArgentina
- Study dates
- 22 Nov 2016to 3 Mar 2017
- Phase
- Observational
- 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
Study population: Patients older than 18 years of age with a history of univisceral liver transplantation since January 2002 for any cause and who have undergone medical follow-up at HIBA
Who may be able to join
- Patients older than 18 years of age with a history of univisceral liver transplantation since January 2002 for any cause and who have undergone medical follow-up at HIBA and had at least one event of liver abscess after transplantation.
Who cannot join
- Patients who died during the hospitalization of the transplant. Patients with parasitic, fungal or amoebic abscesses were excluded. Those patients with subdiaphragmatic or subhepatic abscesses, tumors with abscessed central necrosis were not included in the study either. Patients who underwent liver transplantation at another institution and were then admitted to hospital with a diagnosis of AHP were not included.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires, Peron 4190
Buenos Aires, Buenos Aires F.D., C1199ABB
Diego H Giunta, MD, +54 9 11 5825-6489, diego.giunta@hospitalitaliano.org.ar
About this study
Objective: the aim of this study is to identify risk factors associated with the development of pyogenic liver abscesses (PLA) in adult liver recipients (ALR) and to describe the experience of the Hospital Italiano de Buenos Aires (HIBA) in the diagnosis and therapeutic management of these patients.
Background: adult liver recipients differ from the general population with PLA as they exhibit: reconstructed biliary anatomy, recurrent hospitalizations, regular performance status and are subjected to immunosuppression. However, the scientific evidence regarding PLA developed in transplanted organs is still scarce and the management of this disease continues to be based on experience in non-transplanted patients.
Methods: between 1996 and 2016, 879 adult patients underwent liver transplantation (LT) at our institution. Patients who developed PLA after LT (cases) and controls are matched according to the time from transplant to abscess in a 1 to 5 relation. The investigators performed a logistic regression model to establish PLA risk factors considering clusters for matched cases and controls. Independent risk factors will be identified using multivariate regression analysis.
Read the detailed description
Objective: the aim of this study is to identify risk factors associated with the development of pyogenic liver abscesses (PLA) in adult liver recipients (ALR) and to describe the experience of the Hospital Italiano de Buenos Aires (HIBA) in the diagnosis and therapeutic management of these patients.
Background: adult liver recipients differ from the general population with PLA as they exhibit: reconstructed biliary anatomy, recurrent hospitalizations, regular performance status and are subjected to immunosuppression. However, the scientific evidence regarding PLA developed in transplanted organs is still scarce and the management of this disease continues to be based on experience in non-transplanted patients.
Methods: between 1996 and 2016, 879 adult patients underwent liver transplantation (LT) at our institution. Patients who developed PLA after LT (cases) and controls are matched according to the time from transplant to abscess in a 1 to 5 relation. The investigators performed a logistic regression model to establish PLA risk factors considering clusters for matched cases and controls. Independent risk factors will be identified using multivariate regression analysis.
- Conditions
- Liver Transplant Abscess
- Keywords
- Pyogenic Liver abscess, Liver transplantation, Biliary disease
- Medical subject headings
- Liver Abscess, Pyogenic, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I - Cases | Patients older than 18 years of age with a history of liver transplantation since January 2002 for any cause and who have undergone medical follow-up at HIBA and had at least one event of pyogenic liver abscess after transplantation. | |
| Group II - Controls | Patients older than 18 years with a history of liver transplantation since January 2002 for any cause and who have performed their medical follow-up at HIBA without developing any event of pyogenic liver abscess after transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a pyogenic liver abscess after liver transplantation
The diagnosis of hepatic abscess was based on clinical findings, evidence obtained from imaging studies, blood cultures, purulent material obtained from punctures, intraoperative findings and resolution after antibacterial chemotherapy, and one of the following scenarios could be found:
to. Findings of one or more intrahepatic images of liquid characteristics by means of ultrasound and / or CT scan associated with suspected hepatic abscess based on the clinical picture, laboratory tests and / or microbiological study.
- Finding one or more intrahepatic images of liquid characteristics by means of US and / or CT, with posterior drainage of pus.
Measured: January 1996 and December 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start22 Nov 2016
- Primary completion2 Mar 2017 (estimated)
- Study completion3 Mar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant AbscessStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064685
- Sponsor's protocol ID
- 3087
- Status last verified
- Mar 2017
- First submitted
- 22 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Outcomes of Pyogenic Liver Abscess in Adult Liver Recipients: A Match Case Control Study
- ClinicalTrials.gov ID
- NCT03064685
- Acronym / sponsor ID
- 3087
- Conditions
- Liver Transplant Abscess
- Keywords
- Pyogenic Liver abscess, Liver transplantation, Biliary disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 2 Mar 2017 (estimated)
- Study completion
- 3 Mar 2017 (estimated)
- First posted
- 27 Feb 2017 (actual)
- 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.
Objective: the aim of this study is to identify risk factors associated with the development of pyogenic liver abscesses (PLA) in adult liver recipients (ALR) and to describe the experience of the Hospital Italiano de Buenos Aires (HIBA) in the diagnosis and therapeutic management of these patients.
Background: adult liver recipients differ from the general population with PLA as they exhibit: reconstructed biliary anatomy, recurrent hospitalizations, regular performance status and are subjected to immunosuppression. However, the scientific evidence regarding PLA developed in transplanted organs is still scarce and the management of this disease continues to be based on experience in non-transplanted patients.
Methods: between 1996 and 2016, 879 adult patients underwent liver transplantation (LT) at our institution. Patients who developed PLA after LT (cases) and controls are matched according to the time from transplant to abscess in a 1 to 5 relation. The investigators performed a logistic regression model to establish PLA risk factors considering clusters for matched cases and controls. Independent risk factors will be identified using multivariate regression analysis.
Detailed description
Objective: the aim of this study is to identify risk factors associated with the development of pyogenic liver abscesses (PLA) in adult liver recipients (ALR) and to describe the experience of the Hospital Italiano de Buenos Aires (HIBA) in the diagnosis and therapeutic management of these patients.
Background: adult liver recipients differ from the general population with PLA as they exhibit: reconstructed biliary anatomy, recurrent hospitalizations, regular performance status and are subjected to immunosuppression. However, the scientific evidence regarding PLA developed in transplanted organs is still scarce and the management of this disease continues to be based on experience in non-transplanted patients.
Methods: between 1996 and 2016, 879 adult patients underwent liver transplantation (LT) at our institution. Patients who developed PLA after LT (cases) and controls are matched according to the time from transplant to abscess in a 1 to 5 relation. The investigators performed a logistic regression model to establish PLA risk factors considering clusters for matched cases and controls. Independent risk factors will be identified using multivariate regression analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Cases | – | –Patients older than 18 years of age with a history of liver transplantation since January 2002 for any cause and who have undergone medical follow-up at HIBA and had at least one event of pyogenic liver abscess after transplantation. |
| Group II - Controls | – | –Patients older than 18 years with a history of liver transplantation since January 2002 for any cause and who have performed their medical follow-up at HIBA without developing any event of pyogenic liver abscess after transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years of age with a history of univisceral liver transplantation since January 2002 for any cause and who have undergone medical follow-up at HIBA
Key inclusion criteria (1 listed)
- Patients older than 18 years of age with a history of univisceral liver transplantation since January 2002 for any cause and who have undergone medical follow-up at HIBA and had at least one event of liver abscess after transplantation.
Key exclusion criteria (1 listed)
- Patients who died during the hospitalization of the transplant. Patients with parasitic, fungal or amoebic abscesses were excluded. Those patients with subdiaphragmatic or subhepatic abscesses, tumors with abscessed central necrosis were not included in the study either. Patients who underwent liver transplantation at another institution and were then admitted to hospital with a diagnosis of AHP were not included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of a pyogenic liver abscess after liver transplantation
Time frame: January 1996 and December 2016
The diagnosis of hepatic abscess was based on clinical findings, evidence obtained from imaging studies, blood cultures, purulent material obtained from punctures, intraoperative findings and resolution after antibacterial chemotherapy, and one of the following scenarios could be found: to. Findings of one or more intrahepatic images of liquid characteristics by means of ultrasound and / or CT scan associated with suspected hepatic abscess based on the clinical picture, laboratory tests and / or microbiological study. B. Finding one or more intrahepatic images of liquid characteristics by means of US and / or CT, with posterior drainage of pus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Abscess, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. 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 Argentina. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matias Czerwonko, MD (91151215991, matias.czerwonko@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a pyogenic liver abscess after liver transplantation (time frame: January 1996 and December 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2017.