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Clinical Trials/NCT04717869
NCT04717869
Recruiting
Not Applicable

Identifying Modifiable PAtient Centered Therapeutics Frailty: An Observational Cohort Study

University of California, Los Angeles1 site in 1 country250 target enrollmentSeptember 22, 2023

Overview

Phase
Not Applicable
Intervention
Ultrasound
Conditions
Frailty
Sponsor
University of California, Los Angeles
Enrollment
250
Locations
1
Primary Endpoint
Discharge Disposition
Status
Recruiting
Last Updated
3 months ago

Overview

Brief Summary

Frailty, the decline in physical and cognitive reserves leading to vulnerability to stressors is increasingly being recognized as a public health concern. Although multiple measures exist that can identify frail patients, very little is known about how or when to intervene. Sarcopenia, or the degree of muscle wasting, is closely correlated to frailty and patient outcomes. This is a prospective cohort study of critically ill patients to identify modifiable risk factors of sarcopenia, as potential targets to reduce frailty.

Detailed Description

Frailty is the decline in physical and cognitive reserves leading to increased vulnerability to stressors such as surgery or disease states. Frailty is not a disease, but a syndrome with a distinct frail phenotype that includes decreased status in mobility, muscle mass, nutritional status, strength, and endurance. Frail patients are at greater risk of adverse outcomes, such as functional decline, prolonged hospitalization with associated increases in healthcare costs and death. Multiple measures of frailty exist and although they are important for understanding risk for a given patient population or resource utilization, they do not provide any insight as to how to manage or treat frail patients. In critically ill patients, sarcopenia has long been tied to poor outcomes, poor nutrition status, and decreased ability to perform activities of daily living (ADLs). We hypothesize that sarcopenia as a marker for frailty in critically ill patients can be used to track development and recovery of frailty. The objective of this proposal to create a prospective cohort study of critically ill patients to identify modifiable risk factors of sarcopenia as potential targets for therapeutic measures to improve or reverse frailty. The primary aim of the study is to track sarcopenia in critically ill patients. Sarcopenia is a measure of frailty and is associated with worse outcomes in critically ill patients. The aim to understand how the kinetics of sarcopenia differ in critically ill population given the heterogeneity of with various disease process which may affect the degree and rate of muscle wasting. Understanding the disease process is important in identifying when or how to intervene to obtain meaningful recovery. Secondary aims are to assess the role biomarkers in patients across the frailty spectrum to understand their role frailty. Additionally nutrition is well known to affect sarcopenia and nutritional status is a key component in frailty. Nutrition status will be tracked to understand development of sarcopenia.

Registry
clinicaltrials.gov
Start Date
September 22, 2023
End Date
July 1, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cecilia Canales

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • Adult patients admitted to the Surgical, Cardiothoracic or Neuro ICU
  • ICU stay longer than 24 hours

Exclusion Criteria

  • Patients with muscular or mitochondrial diseases affecting muscle quality or mass
  • Preexisting paralysis
  • Absence of lower limbs
  • Ongoing discussions about goals of care
  • Transfers from a skilled nursing facility
  • Children under the age of 18

Arms & Interventions

ICU Patients

Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission

Intervention: Ultrasound

ICU Patients

Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission

Intervention: Biomarker Analysis

ICU Patients

Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission

Intervention: Frailty Index

Outcomes

Primary Outcomes

Discharge Disposition

Time Frame: Patients will be followed from enrollment to hospital discharge. Approximately 2 weeks to 2 months

Disposition of patient at time of hospital discharge, home, rehabilitation or skilled nursing facility, in hospital death

Length of Hospital stay

Time Frame: Patients will be followed from enrollment until discharge from the hospital. Approximately 2 weeks to 2 months

Length of time patient is admitted to the hospital including length of time patient spends in the ICU until discharge or death

Length of ICU stay

Time Frame: Patients will be followed from enrollment to ICU transfer. Approximately 2 weeks to 2 months

Length of time patient is admitted to ICU until transfer out of the ICU

Secondary Outcomes

  • Adverse Events(Patients will be followed from enrollment to 1 year.)

Study Sites (1)

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