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

September 27, 2023 updated by: Cecilia Canales, University of California, Los Angeles

Identifying Modifiable PAtient Centered Therapeutics Frailty: An Observational Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
        • Contact:
        • Principal Investigator:
          • Cecilia Canales, MD, MPH
        • Sub-Investigator:
          • Maxime Cannesson, MD, Ph.D
        • Sub-Investigator:
          • Vadim Gudzenko, MD
        • Sub-Investigator:
          • Sumit Singh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to the the Surgical, Cardiothoracic, or Neuro ICU.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Patients will be followed from enrollment to hospital discharge. Approximately 2 weeks to 2 months
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
Patients will be followed from enrollment to ICU transfer. Approximately 2 weeks to 2 months
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
Patients will be followed from enrollment until discharge from the hospital. Approximately 2 weeks to 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Patients will be followed from enrollment to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Cecilia Canales, MD, MPH, UCLA Department of Anesthesiology and Perioperative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 17, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-002271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will not be shared outside the study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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