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

Sponsor
Methodist Health System (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05935800
Collaborator
(none)
208
1
24
8.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMC

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 Design

Study Type:
Observational
Anticipated Enrollment :
208 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates
Actual Study Start Date :
Apr 19, 2022
Anticipated Primary Completion Date :
Apr 19, 2024
Anticipated Study Completion Date :
Apr 19, 2024

Outcome Measures

Primary Outcome Measures

  1. To determine the impact of the COVID-19 pandemic on the prevalence and incidence of sarcopenia [2 years]

    To determine the impact of the COVID-19 pandemic on the prevalence and incidence of sarcopenia and frailty in patients undergoing liver transplant evaluation at Methodist Dallas Medical Center (MDMC).

Secondary Outcome Measures

  1. Changes in sarcopenia [1 yr]

    Changes in number, type, and severity of comorbidities between pre- and during/post-pandemic

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Dallas Medical Center Dallas Texas United States 75203

Sponsors and Collaborators

  • Methodist Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT05935800
Other Study ID Numbers:
  • 012.HEP.2022.D
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2023