The Liver Transplant Infectious Diseases Modified Prospective Cohort Study

Shmuel Shoham, MD

Abstract

The proposed study will characterize the epidemiology, risk factors, and outcomes of infections in patients receiving liver transplantation at Sun Yat-sen University (SYSU) and compare those to a contemporaneous group of liver transplant recipients at Johns Hopkins University (JHU). Liver transplant recipients are at heightened risk for potentially life threatening infections. The landscape of liver transplantation in China has been transformed in recent years with the introduction of novel transplantation protocols and changes in criteria for suitable donors and recipients. These changes are altering the epidemiology of post liver transplant infections in China. An up to date understanding of the epidemiology of such infections is essential for developing prevention, diagnosis and treatment algorithms. However, studies informing development of such algorithms have generally been performed outside of China with populations that may differ in basic demographic and clinical characteristics.

The epidemiology and outcomes of infections in Chinese liver transplant recipients differ from those in the US and suggest that prevention, diagnosis and treatment algorithms currently used at US medical centers may not adequately address the needs of Chinese patients.

This will be a modified prospective cohort study. Liver transplant recipients that are ā‰„ 18 years of age will be recruited to participate in this study at SYSU. Concurrent patients at JHU will serve as a comparison group. Consenting participants will be followed for 6 months at 3 months intervals. Information relating to underlying disease, transplantation, infections, antimicrobials and complications will be collected by reviewing medical records and by contacting the participants directly. Standardized definitions will be used to code infectious outcomes and data will be stored and managed using an electronic database (REDCap). Throughout the study, emphasis will be placed on sharing of clinical research practices and expertise between JHU and SYSU with goal of developing this type of research mechanism within China.

Descriptive analyses will be performed in order to determine the rate of the various types of infectious complications. Identification of individual and combinations of risk factors for development of such infections and evaluation of the impact of infections on all-cause mortality will be performed using univariate analysis and multivariable conditional logistic regression models.

Longer term goals of this project are to: A) Employ the mechanisms and local expertise developed during this pilot program for expansion of this study to include additional solid organ transplant types and hematopoietic stem cell transplant recipients in China and with longer follow up periods, and B) Utilize data gained through this study to evaluate and develop improved prevention, diagnosis and early treatment protocols for transplant recipients in China.