Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty

Recruiting

• Conditions: Sarcopenia; Frailty
• Interventions: Diagnostic Test: Ultrasound; Diagnostic Test: Biomarker Analysis; Other: Frailty Index

• Registration Number: NCT04717869
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-17
• Study First Posted: 2021-01-22
• Study Start: 2023-09-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-05
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU Patients	Ultrasound	Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission
ICU Patients	Biomarker Analysis	Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission
ICU Patients	Frailty Index	Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission

Primary Outcome Measures

Name	Time	Method
Discharge Disposition	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	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	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 Outcome Measures

Name	Time	Method
Adverse Events	Patients will be followed from enrollment to 1 year.	Falls, fractures, number of emergency room visits, number of times hospitalized, total hospital days and mortality

Trial Locations

Locations (1)

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine; 🇺🇸 Los Angeles, California, United States