Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty

Sarcopenia Clinical Trial

— IMPACT  

Official title:

Identifying Modifiable PAtient Centered Therapeutics Frailty: An Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04717869
• Other study ID #: 20-002271
• Status: Recruiting
• Start date: September 22, 2023
• Est. completion date: July 2026

Study information

• Verified date: September 2023
• Source: University of California, Los Angeles
• Contact: Jennifer Scovotti, MA
• Phone: 3102064484
• Email: jscovotti[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Sarcopenia

Intervention

Diagnostic Test:
• Ultrasound
2D ultrasound image collection
• Biomarker Analysis
Inflammatory and nutritional biomarker analysis

Other:
• Frailty Index
A Frailty Index Questionnaire be completed by patients or their surrogates to determine the presence of frailty at ICU admission

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discharge Disposition	Disposition of patient at time of hospital discharge, home, rehabilitation or skilled nursing facility, in hospital death	Patients will be followed from enrollment to hospital discharge. Approximately 2 weeks to 2 months
Primary	Length of ICU stay	Length of time patient is admitted to ICU until transfer out of the ICU	Patients will be followed from enrollment to ICU transfer. Approximately 2 weeks to 2 months
Primary	Length of Hospital stay	Length of time patient is admitted to the hospital including length of time patient spends in the ICU until discharge or death	Patients will be followed from enrollment until discharge from the hospital. Approximately 2 weeks to 2 months
Secondary	Adverse Events	Falls, fractures, number of emergency room visits, number of times hospitalized, total hospital days and mortality	Patients will be followed from enrollment to 1 year.