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临床试验/NCT04717869
NCT04717869招募中不适用

Identifying Modifiable PAtient Centered Therapeutics Frailty: An Observational Cohort Study

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年9月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
Discharge Disposition

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

ICU Patients

Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission

干预措施: Ultrasound (Diagnostic Test)

ICU Patients

Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission

干预措施: Biomarker Analysis (Diagnostic Test)

ICU Patients

Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission

干预措施: Frailty Index (Other)

结局指标

主要结局

Discharge Disposition

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • Adverse Events(Patients will be followed from enrollment to 1 year.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cecilia Canales

Principal Investigator

University of California, Los Angeles

研究点 (1)

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