Functional Assessment in Liver Transplantation

Официальное название

Functional Assessment in Liver Transplant Candidates (FrAILT) Study

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Frailty and functional status as assessed by grip strength, chair stands, and balance which comprise the Liver Frailty Index (LFI). [Срок оценки: December 31, 2023]
• Examine the association between frailty and outcomes both before and after liver transplantation. [Срок оценки: December 31, 2023]
• Evaluate the change in frailty and physical function both before and after liver transplant or treatment utilizing the LFI. [Срок оценки: December 31, 2023]

Критерии участия

Критерии включения

• Adult (≥18 years old)
• Are seen for the treatment of liver disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 12 центров

• University of Arkansas for Medical Sciences — Little Rock
• Loma Linda University — Loma Linda
• University of California, San Francisco — San Francisco
• Northwestern University — Chicago
• Indiana University — Indianapolis
• Johns Hopkins — Baltimore
• University of Michigan — Ann Arbor
• Columbia University — New York
• … и ещё 4 центра

Публикации

• Lai JC, Feng S, Terrault NA, Lizaola B, Hayssen H, Covinsky K. Frailty predicts waitlist mortality in liver transplant candidates. Am J Transplant. 2014 Aug;14(8):1870-9. doi: 10.1111/ajt.12762. Epub 2014 Jun 16. PMID 24935609
• Lai JC, Covinsky KE, Hayssen H, Lizaola B, Dodge JL, Roberts JP, Terrault NA, Feng S. Clinician assessments of health status predict mortality in patients with end-stage liver disease awaiting liver transplantation. Liver Int. 2015 Sep;35(9):2167-73. doi: 10.1111/liv.12792. Epub 2015 Feb 12. PMID 25644788
• Wang CW, Covinsky KE, Feng S, Hayssen H, Segev DL, Lai JC. Functional impairment in older liver transplantation candidates: From the functional assessment in liver transplantation study. Liver Transpl. 2015 Dec;21(12):1465-70. doi: 10.1002/lt.24334. Epub 2015 Nov 6. PMID 26359787
• Lai JC, Dodge JL, Sen S, Covinsky K, Feng S. Functional decline in patients with cirrhosis awaiting liver transplantation: Results from the functional assessment in liver transplantation (FrAILT) study. Hepatology. 2016 Feb;63(2):574-80. doi: 10.1002/hep.28316. Epub 2015 Dec 16. PMID 26517301
• Wang CW, Feng S, Covinsky KE, Hayssen H, Zhou LQ, Yeh BM, Lai JC. A Comparison of Muscle Function, Mass, and Quality in Liver Transplant Candidates: Results From the Functional Assessment in Liver Transplantation Study. Transplantation. 2016 Aug;100(8):1692-8. doi: 10.1097/TP.0000000000001232. PMID 27314169
• Lai JC, Volk ML, Strasburg D, Alexander N. Performance-Based Measures Associate With Frailty in Patients With End-Stage Liver Disease. Transplantation. 2016 Dec;100(12):2656-2660. doi: 10.1097/TP.0000000000001433. PMID 27495749
• Sinclair M, Poltavskiy E, Dodge JL, Lai JC. Frailty is independently associated with increased hospitalisation days in patients on the liver transplant waitlist. World J Gastroenterol. 2017 Feb 7;23(5):899-905. doi: 10.3748/wjg.v23.i5.899. PMID 28223735
• Berry KA, Kent D, Seetharaman S, Wong R, Mohamad Y, Yao F, Nunez-Duarte M, Wadhwani SI, Boyarsky BJ, Rahimi RS, Duarte-Rojo A, Kappus MR, Volk ML, Ladner DP, Segev DL, McAdams-DeMarco M, Verna EC, Ganger DR, Lai JC. Loneliness in adults awaiting liver transplantation at 7 U.S. transplant centers. Ann Hepatol. 2022 Sep-Oct;27(5):100718. doi: 10.1016/j.aohep.2022.100718. Epub 2022 Apr 20. PMID 35460882

Идентификаторы

NCT: NCT03228290 · 11-07513 · 1R21AG067554 · R21DK127275

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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