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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• COVID-19
• Frailty
• Sarcopenia

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