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Active, Not Recruiting

NCT Number: NCT05935800

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

Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures. 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Frailty Atrophy COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nidovirales Infections Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sarcopenia Signs and Symptoms Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

This study seeks to examine whether the (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMC

Behavioral

This is a single-center, retrospective study that uses de-identified, anonymized patient data. Data from 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.

Primary outcomes

  1. 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. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jul 7, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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