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

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ClinicalTrials.gov Identifier: NCT03064685
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires

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.


Condition or disease
Liver Transplant Abscess

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
Estimated Enrollment : 126 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Risk Factors and Outcomes of Pyogenic Liver Abscess in Adult Liver Recipients: A Match Case Control Study
Actual Study Start Date : November 22, 2016
Estimated Primary Completion Date : March 2, 2017
Estimated Study Completion Date : March 3, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064685


Contacts
Contact: Matias Czerwonko, MD 91151215991 matias.czerwonko@hospitalitaliano.org.ar

Locations
Argentina
Hospital Italiano de Buenos Aires, Peron 4190 Recruiting
Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
Contact: Diego H Giunta, MD    +54 9 11 5825-6489    diego.giunta@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires

Responsible Party: Diego Hernan Giunta, MD, Clinical Professor, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT03064685     History of Changes
Other Study ID Numbers: 3087
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires:
Pyogenic Liver abscess
Liver transplantation
Biliary disease

Additional relevant MeSH terms:
Liver Abscess
Liver Abscess, Pyogenic
Liver Diseases
Liver Extracts
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Abdominal Abscess
Digestive System Diseases
Hematinics