End Stage Liver Disease
Conditions
Keywords
Cirrhosis, Liver, Liver Transplant, Frailty, end stage
Brief summary
This will be a prospective cohort study of patients with liver disease. Subjects will undergo geriatric assessments of frailty, functional status, and disability using functional status measures at baseline and at every clinic visit in the pre-transplant setting. Subjects will also answer questions regarding quality of life, personality, and/or cognitive function. Subjects will again undergo assessments at every clinic visit through 12 months after transplant. Then, they will be followed annually.
Detailed description
Patients will be asked to perform the following study procedures: 1. Assessment of cognitive function, quality of life, and/or personality using cognitive tests and questionnaires. 2. Measures of frailty and disability selected to capture the multi-dimensional aspects of frailty including functional status and physiologic reserve: Fried Frailty Score: weakness (test of grip strength), exhaustion (patient interview), slowness (gait speed), low activity (patient interview) Short Physical Performance Battery: repeated chair stands, balance testing with feet together, 13-foot walk 3. Laboratory tests will all be obtained from the medical record: creatinine, total bilirubin, INR, sodium, albumin. All of these tests are necessary for listing for liver transplantation. 4. Blood draw, urine and stool samples will be collected for a sub-group of 1000 patients. 5. Adipose, muscle, liver tissue, and blood will be collected during the liver transplant surgery for a sub-group of 1000 patients.
Interventions
None listed
Sponsors
University of California, San Francisco
National Institute on Aging (NIA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (≥18 years old) * Are seen for the treatment of liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frailty and functional status as assessed by grip strength, chair stands, and balance which comprise the Liver Frailty Index (LFI). | December 31, 2023 | Grip strength: Performance-based. Measured in kilograms. This was measured in each subject's dominant hand using a hand dynamometer (Jamar Hydraulic hand dynamometer). We averaged three trials. Chair stands: Performance-based. Measured in number of chair stands per second. Number of chair stands completed in 30 seconds. Balance: Performance-based. Measured in seconds. Ability to balance in three positions (feet placed side to side, semitandem, and tandem) for 10 seconds each. Liver Frailty Index (LFI): (coefficient x grip) + (coefficient x chair stands) + (coefficient x balance) +6 |
| Examine the association between frailty and outcomes both before and after liver transplantation. | December 31, 2023 | Outcomes measured prior to transplant will include: waiting for transplant, died pre-transplant, deactivated too sick, deactivated for social reasons/inactive, deferred not a candidate, and transplanted. Outcomes that will be measured post transplant include: still alive, died post transplant, and re-transplanted. All measures will be acquired via patient interview or review of medical records. |
| Evaluate the change in frailty and physical function both before and after liver transplant or treatment utilizing the LFI. | December 31, 2023 | See outcome 1 for how LFI is measured. |
Countries
United States
Contacts
CONTACTJennifer C Lai, MD, MBA
CONTACTFawzy Barry, BS
PRINCIPAL_INVESTIGATORJennifer C Lai, MD, MBA
University of California, San Francisco
Outcome results
None listed