Functional Assessment in Liver Transplantation

NCT03870568 | Terminated DMC

• 1 other identifier: 015-243
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

Brief Summary

In order to ensure the equity of the liver allocation process, it is important to create objective, scientifically validated markers of frailty in patients with end-stage liver disease that accurately predict patient outcomes. Many measures have been developed to assess this clinical state in elderly patients, but none have been applied to patients with cirrhosis, a population at increased risk for accelerated functional decline. This protocol is designed to learn more about the effects of functional status (also known as "frailty") in liver transplant patients and patient outcomes both before and after liver transplant.

Conditions

Cirrhosis; End Stage Liver Disease

Keywords

frailty; liver transplantation; functional status

Outcome Measures

Primary Outcomes (8)

• Fried Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation

  Fried Frailty is calculated by combining into one score measurements of: * Exhaustion: number of days patient felt exhaustion in the past 7 days * Physical activity: has the subject performed any weight bearing activity in the past month? (Possible answers: yes or no). * Grip strength test using dynamometer: Three measurements reported in kg. * Walking speed in a 13-foot (4 meters) walk: Three measurements reported in seconds * Unintentional Weight Loss: report if patient has lost 10 lbs or more in the last year. * Minnesota Leisure Time Physical Activity Questionnaire (MNLTPA) calculated as a value of 1 for males with MNLTPA score less than 383 kcal/week and for females with a score less than 270 kcal/week. Range of score is 0 to 5 with 0 being not frail and 5 being most frail

  5 years

• Liver Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation

  The following measurements are used individually to assess liver frailty index: Chair stands: The patient stands up from a sitting position without using his/her arms. The time (in seconds) the patient requires to complete the task is reported. Balance testing: patients must stand up in side by side, semi tandem and tandem positions for 10 seconds each. If the subject can't hold position for 10 seconds, the number of seconds that the subject kept in position is reported. Scoring range is 1.0 to 7.0 with 1.0 to 3.0 being "robust" and 4.5 to 7.0 being "frail"

  5 years

• Numbers Connection test measurements in 300 patients with end-stage liver disease

  Patient connects numbers that are scattered at random on a piece of paper. Reported as time (in seconds) taken to connect the numbers.

  5 years

• Work status

  Possible answers: working, retired, on disability, other.

  5 years

• Hospitalizations

  Possible answers: yes or no. If yes, report #of nights and reason.

  5 years

• Activities of daily living (ADLs)

  Six questions about daily activities Scoring: A response of yes to any of the questions receives a value of 1. the ADL score is measured as the sum of the values of the 6 questions. A score of 0 correlates with "most dependent" and a score of 6 is "most independent."

  At 1 year post transplantation

• Instrumental Activities of Daily Living (IADLs)

  Eight questions about daily activities: Scoring: each question can be answered with a score of 0 or 1. The final iADL score is the sum of all values. The range of the score is 0 to 8 with 0 being most dependent and 8 being "most independent.'

  At 1 year post transplantation

• 36 Item Short Form Survey Instrument (SF-36)

  Patient will complete a 36 question questionnaire about quality of life at 1 year post transplantation.

  At 1 year post transplantation

Secondary Outcomes (1)

• Correlation between frailty and outcomes both before and after liver transplantation.

  5 years

Other Outcomes (2)

• Change in measurements of fried frailty before and after liver transplantation.

  5 years

• Change in measurements of liver frailty before and after liver transplantation.

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Enrolled from Baylor University Medical Center.

You may qualify if:

• Adults (≥18 years old)
• Listed for liver transplantation, or are "listable" - i.e, have undergone formal evaluation and been approved for listing if/when patients achieve high enough priority
• Are seen in the outpatient clinic setting

You may not qualify if:

• Have severe hepatic encephalopathy at enrollment (defined by the time to complete the Numbers Connection Test (NCT) \> 120 seconds, which is the first test that the participants complete upon enrollment).

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Fibrosis; End Stage Liver Disease; Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• James Trotter, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 12, 2019
• Study Start: October 6, 2015
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)