Clinical trial NCT04717869: Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Official title: Identifying Modifiable PAtient Centered Therapeutics Frailty: an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Sarcopenia
Keywords: Frailty
Sarcopenia
Ultrasound
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the the Surgical, Cardiothoracic, or Neuro ICU.

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.

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

Primary outcomes:
measure: Discharge Disposition
timeFrame: Patients will be followed from enrollment to hospital discharge. Approximately 2 weeks to 2 months
measure: Length of ICU stay
timeFrame: Patients will be followed from enrollment to ICU transfer. Approximately 2 weeks to 2 months
measure: Length of Hospital stay
timeFrame: Patients will be followed from enrollment until discharge from the hospital. Approximately 2 weeks to 2 months
Secondary outcomes:
measure: Adverse Events
timeFrame: Patients will be followed from enrollment to 1 year.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
state: California
Study officials:
affiliation: UCLA Department of Anesthesiology and Perioperative Medicine
name: Cecilia Canales, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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