Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty

Official title

Identifying Modifiable PAtient Centered Therapeutics Frailty: An Observational Cohort Study

Overview

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.

Interventions

• 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

Primary outcome measures

• Discharge Disposition [Time frame: 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 Hospital stay [Time frame: Patients will be followed from enrollment until discharge from the hospital. Approximately 2 weeks to 2 months]

Secondary outcome measures (1)

• Adverse Events [Time frame: Patients will be followed from enrollment to 1 year.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine — Los Angeles

Publications

• Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6. PMID 31609228
• Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009. PMID 21093718
• Op het Veld LP, van Rossum E, Kempen GI, de Vet HC, Hajema K, Beurskens AJ. Fried phenotype of frailty: cross-sectional comparison of three frailty stages on various health domains. BMC Geriatr. 2015 Jul 9;15:77. doi: 10.1186/s12877-015-0078-0. PMID 26155837
• Ritt M, Schwarz C, Kronawitter V, Delinic A, Bollheimer LC, Gassmann KG, Sieber CC. Analysis of Rockwood et Al's Clinical Frailty Scale and Fried et Al's Frailty Phenotype as Predictors of Mortality and Other Clinical Outcomes in Older Patients Who Were Admitted to a Geriatric Ward. J Nutr Health Aging. 2015 Dec;19(10):1043-8. doi: 10.1007/s12603-015-0667-9. PMID 26624218
• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051. PMID 16129869
• Zylberglait Lisigurski M, Bueno YA, Karanam C, Andrade AD, Akkineni S, Cevallos V, Ruiz JG. Healthcare Utilization by Frail, Community-Dwelling Older Veterans: A 1-Year Follow-up Study. South Med J. 2017 Nov;110(11):699-704. doi: 10.14423/SMJ.0000000000000722. PMID 29100219
• Eamer G, Gibson JA, Gillis C, Hsu AT, Krawczyk M, MacDonald E, Whitlock R, Khadaroo RG. Surgical frailty assessment: a missed opportunity. BMC Anesthesiol. 2017 Jul 24;17(1):99. doi: 10.1186/s12871-017-0390-7. PMID 28738809
• Lim WS, Wong SF, Leong I, Choo P, Pang WS. Forging a Frailty-Ready Healthcare System to Meet Population Ageing. Int J Environ Res Public Health. 2017 Nov 24;14(12):1448. doi: 10.3390/ijerph14121448. PMID 29186782

Identifiers

NCT: NCT04717869 · 20-002271

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗