The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates

November 13, 2023 updated by: Methodist Health System
Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures [1]. Sarcopenia is degenerative loss of skeletal muscle mass and strength. It is a key component of physical frailty and is associated with poorer post-surgical outcomes due to decreased patient strength and vitality.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study seeks to examine whether the SARS-CoV-2 (COVID-19) pandemic, an ongoing global health crisis that was declared a national emergency by the US Federal Government on March 13, 2020, has exacerbated both frailty and sarcopenia in a population of liver transplant candidates.

Study Type

Observational

Enrollment (Estimated)

208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC 369 liver transplant candidates who underwent pre-transplant frailty assessments at the Liver Institute at Methodist Dallas from April 1, 2018 to February 28, 2022. The study data will be divided into cohorts: pre-COVID and COVID. Specifically, the pre-COVID period will consist of the dates between April 1st, 2018 and March 12, 2020, while the COVID period will consist of the dates between March 13, 2020 and February 28th, 2022.

Description

Inclusion Criteria:

  • Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC

Exclusion Criteria:

  • Not a patient at Liver Institute at Methodist Dallas

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia
Time Frame: 2 years
To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia and frailty in patients undergoing liver transplant evaluation at Methodist Dallas Medical Center
2 years
To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia
Time Frame: 2 years
To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia and frailty in patients undergoing liver transplant evaluation at Methodist Dallas Medical Center
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in number of comorbidities between pre- and during/post-pandemic periods
Time Frame: 1 year
Changes in number of comorbidities between pre- and during/post-pandemic periods
1 year
Changes in type of comorbidities between pre- and during/post-pandemic periods
Time Frame: 1 year
Changes in type of comorbidities between pre- and during/post-pandemic periods
1 year
Changes in severity of comorbidities between pre- and during/post-pandemic periods
Time Frame: 1 year
Changes in severity of comorbidities between pre- and during/post-pandemic periods
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Parvez Mantry, MD, Methodist Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2022

Primary Completion (Estimated)

April 19, 2024

Study Completion (Estimated)

April 19, 2024

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012.HEP.2022.D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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