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Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04717869
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Cecilia Canales, 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.

Condition or disease Intervention/treatment
Frailty Sarcopenia Diagnostic Test: Ultrasound Diagnostic Test: Biomarker Analysis Other: Frailty Index

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
ICU Patients
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients admitted to the the Surgical, Cardiothoracic, or Neuro ICU.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jennifer Scovotti, MA 3102064484 jscovotti@mednet.ucla.edu

Locations
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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    jscovotti@mednet.ucla.edu   
Principal Investigator: Cecilia Canales, MD, MPH         
Sub-Investigator: Maxime Cannesson, MD, Ph.D         
Sub-Investigator: Vadim Gudzenko, MD         
Sub-Investigator: Sumit Singh, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Cecilia Canales, MD, MPH UCLA Department of Anesthesiology and Perioperative Medicine
Publications:
Canales C, Mazor E, Flath CS, Vacas S, Duval V, Cannesson M, Umar S, Singh SP. Preoperative Ultrasound Based Frailty Assessment as a Predictor of Surgical Outcomes. Anesthesiology. 2019;131(4):JS-04.

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Responsible Party: Cecilia Canales, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04717869    
Other Study ID Numbers: 20-002271
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will not be shared outside the study team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cecilia Canales, University of California, Los Angeles:
Frailty
Sarcopenia
Ultrasound
Additional relevant MeSH terms:
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Sarcopenia
Frailty
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical