Uses of Immunosuppression Therapy in Patients With Liver Transplantation

Trends of Immunosuppression Therapy and Their Effectiveness in Patients With Liver Transplantation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01834690

Enrollment

314

Registered

2013-04-18

Start date

2013-04-30

Completion date

2014-12-31

Last updated

2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evidence of Liver Transplantation

Keywords

Liver transplantation/epidemiology, Liver transplantation/pharmacology, Health status/drug effects, Agents, immunosuppressive agents

Brief summary

Conventionally, the outcome of liver transplantation is usually reported in terms of graft and patient survival, medical and surgical complications, but lack of health-related quality of life (HRQOL) that might be associated with immunosuppression complications (e.g., diabetes, hypertension, dyslipidemia, obesity, metabolic syndrome, cardiovascular disease, renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections after transplantation.

Detailed description

Specific aims are proposed to achieve in this study: 1. To compare graft and patient survival rate, incidence of treatment-related adverse effects between different patterns of immunosuppression combination among patients received post-liver transplant care in Kaohsiung Chang Gung Memorial Hospital (KCGMH), Taiwan. 2. To quantify the long-term health impacts of immunosuppressive regimens on quality-adjusted life expectancy (QALE), the loss-of-QALE relating to immunosuppression therapy, and types of transplantation.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Aim 1: Inclusion Criteria: * age at liver transplantation is at least 20 years Aim 2: Inclusion Criteria: * age at liver transplantation is at least 20 years

Exclusion criteria

* deceased patient * cannot obtain inform consent * age \<20 years

Design outcomes

Primary

Measure	Time frame	Description
incidence of graft and patient mortality, treatment-related complications	5 years	Patient will be followed from the date of liver transplantation to the occurence of outcome event for 5 years

Secondary

Measure	Time frame	Description
health-related quality of life	5 years	health-related quality of life will be measured by EQ-5D-5L and 15D

Other

Measure	Time frame	Description
quality-adjusted life expectancy (QALE), loss-of-QALE	5 years	QALE:quality-adjusted weight for each health status (measured by EQ-5D)will be multiplied by the survival time and then summed to calculate the number of QALE. Loss-of QALE: the life time expectancy (survival function) for thes study cohort will be compared with Taiwan general population of subjects who are age- and gender-matched with study subjects.

Countries

Taiwan

Outcome results