Clinical Trial: Risk Factors and Outcomes of Pyogenic Liver Abscess in Adult Liver Recipients: A Match Case Control Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Risk Factors and Outcomes of Pyogenic Liver Abscess in Adult Liver Recipients: A Match Case Control Study
Brief 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.
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 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.
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.
Sponsor: Hospital Italiano de Buenos Aires
Current 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Hospital Italiano de Buenos Aires
Dates:
Date Received: February 22, 2017
Date Started: November 22, 2016
Date Completion: March 3, 2017
Last Updated: March 1, 2017
Last Verified: March 2017
