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NCT05935800 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05935800
Other study ID # 012.HEP.2022.D
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 19, 2022
Est. completion date April 19, 2024

Study information
Verified date November 2023
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 208
Est. completion date April 19, 2024
Est. primary completion date April 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMC
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.

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia 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
Primary To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia 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 Changes in number of comorbidities between pre- and during/post-pandemic periods Changes in number of comorbidities between pre- and during/post-pandemic periods 1 year
Secondary Changes in type of comorbidities between pre- and during/post-pandemic periods Changes in type of comorbidities between pre- and during/post-pandemic periods 1 year
Secondary Changes in severity of comorbidities between pre- and during/post-pandemic periods Changes in severity of comorbidities between pre- and during/post-pandemic periods 1 year
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