- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03064685
Risk Factors and Outcomes of Pyogenic Liver Abscess in Adult Liver Recipients: A Match Case Control 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.
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Matias Czerwonko, MD
- Phone Number: 91151215991
- Email: matias.czerwonko@hospitalitaliano.org.ar
Study Locations
-
-
Capital Federal
-
Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
- Recruiting
- Hospital Italiano de Buenos Aires, Peron 4190
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3087
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Inje UniversityPusan National University Yangsan HospitalCompletedCryptogenic Pyogenic Liver AbscessKorea, Republic of
-
Kaohsiung Veterans General Hospital.BayerCompletedLiver AbscessTaiwan
-
Nanfang Hospital of Southern Medical UniversityRecruitingInfections | Abscess | Liver Abscess | Liver Abscess, PyogenicChina
-
Universidad Autonoma de San Luis PotosíInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Hospital... and other collaboratorsCompleted
-
Postgraduate Institute of Medical Education and...Unknown
-
Xiangya Hospital of Central South UniversityCompleted
-
National University Hospital, SingaporeSingapore General Hospital; Tan Tock Seng HospitalCompleted
-
BayerCompletedLiver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.Carcinoma | Liver Neoplasms | Adenoma | Liver AbscessUnited States, Japan, Singapore, Taiwan, Italy
-
Oslo University HospitalSouth-Eastern Norway Regional Health AuthorityNot yet recruitingLiver Metastases | Liver Transplant; Complications | Liver Cancer | Transplant | Transplant; Failure, Liver | Transplant; Complication, Rejection | Transplant Dysfunction
-
University Health Network, TorontoNot yet recruitingSolid Organ Transplant | Liver Transplant | Kidney Transplant | Heart Transplant