Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty (IMPACT)
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|ClinicalTrials.gov Identifier: NCT04717869|
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : April 27, 2021
|Condition or disease||Intervention/treatment|
|Frailty Sarcopenia||Diagnostic Test: Ultrasound Diagnostic Test: Biomarker Analysis Other: Frailty Index|
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 Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Identifying Modifiable PAtient Centered Therapeutics Frailty: An Observational Cohort Study|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||February 2024|
Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission
Diagnostic Test: Ultrasound
2D ultrasound image collection
Diagnostic Test: 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
Other Name: Questionnaire
- 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 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
- 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
- Adverse Events [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717869
|Contact: Jennifer Scovotti, MAfirstname.lastname@example.org|
|United States, California|
|Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Jennifer Scovotti, MA 310-206-4484 email@example.com|
|Principal Investigator: Cecilia Canales, MD, MPH|
|Sub-Investigator: Maxime Cannesson, MD, Ph.D|
|Sub-Investigator: Vadim Gudzenko, MD|
|Sub-Investigator: Sumit Singh, MD|
|Principal Investigator:||Cecilia Canales, MD, MPH||UCLA Department of Anesthesiology and Perioperative Medicine|