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

March 1, 2017 updated by: Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires

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 Overview

Status

Unknown

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 Type

Observational

Enrollment (Anticipated)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Capital Federal
      • Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires, Peron 4190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

January 1996 and December 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 22, 2016

Primary Completion (ANTICIPATED)

March 2, 2017

Study Completion (ANTICIPATED)

March 3, 2017

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (ACTUAL)

February 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Transplant Abscess

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