Risk Factors and Outcomes of Pyogenic Liver Abscess in Adult Liver Recipients: A Match Case Control Study

NCT ID: NCT03064685

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-22

Study Completion Date

2017-03-03

Brief Summary

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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

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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

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Liver Transplant Abscess

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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Diego Hernan Giunta, MD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Italiano de Buenos Aires, Peron 4190

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Matias Czerwonko, MD

Role: CONTACT

91151215991

Facility Contacts

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Diego H Giunta, MD

Role: primary

+54 9 11 5825-6489

Other Identifiers

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3087

Identifier Type: -

Identifier Source: org_study_id

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