NCT04717869

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2023Jul 2026

First Submitted

Initial submission to the registry

January 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2.7 years until next milestone

Study Start

First participant enrolled

September 22, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

January 12, 2021

Last Update Submit

January 28, 2026

Conditions

Keywords

FrailtySarcopeniaUltrasound

Outcome Measures

Primary Outcomes (3)

  • Discharge Disposition

    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

    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

    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 Outcomes (1)

  • Adverse Events

    Patients will be followed from enrollment to 1 year.

Study Arms (1)

ICU Patients

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

Diagnostic Test: UltrasoundDiagnostic Test: Biomarker AnalysisOther: Frailty Index

Interventions

UltrasoundDIAGNOSTIC_TEST

2D ultrasound image collection

ICU Patients
Biomarker AnalysisDIAGNOSTIC_TEST

Inflammatory and nutritional biomarker analysis

ICU Patients

A Frailty Index Questionnaire be completed by patients or their surrogates to determine the presence of frailty at ICU admission

Also known as: Questionnaire
ICU Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (29)

  • 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: 31609228BACKGROUND
  • 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: 21093718BACKGROUND
  • 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: 26155837BACKGROUND
  • 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: 26624218BACKGROUND
  • 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: 16129869BACKGROUND
  • 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: 29100219BACKGROUND
  • 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: 28738809BACKGROUND
  • 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: 29186782BACKGROUND
  • Hastings SN, Purser JL, Johnson KS, Sloane RJ, Whitson HE. Frailty predicts some but not all adverse outcomes in older adults discharged from the emergency department. J Am Geriatr Soc. 2008 Sep;56(9):1651-7. doi: 10.1111/j.1532-5415.2008.01840.x. Epub 2008 Aug 4.

    PMID: 18691282BACKGROUND
  • Lin H, Peel NM, Scott IA, Vardesh DL, Sivalingam P, McBride RL, Morong JJ, Nelson MJ, Hubbard RE. Perioperative assessment of older surgical patients using a frailty index-feasibility and association with adverse post-operative outcomes. Anaesth Intensive Care. 2017 Nov;45(6):676-682. doi: 10.1177/0310057X1704500605.

    PMID: 29137576BACKGROUND
  • Lin HS, Watts JN, Peel NM, Hubbard RE. Frailty and post-operative outcomes in older surgical patients: a systematic review. BMC Geriatr. 2016 Aug 31;16(1):157. doi: 10.1186/s12877-016-0329-8.

    PMID: 27580947BACKGROUND
  • Robinson TN, Wu DS, Pointer L, Dunn CL, Cleveland JC Jr, Moss M. Simple frailty score predicts postoperative complications across surgical specialties. Am J Surg. 2013 Oct;206(4):544-50. doi: 10.1016/j.amjsurg.2013.03.012. Epub 2013 Jul 20.

    PMID: 23880071BACKGROUND
  • Smart R, Carter B, McGovern J, Luckman S, Connelly A, Hewitt J, Quasim T, Moug S. Frailty Exists in Younger Adults Admitted as Surgical Emergency Leading to Adverse Outcomes. J Frailty Aging. 2017;6(4):219-223. doi: 10.14283/jfa.2017.28.

    PMID: 29165541BACKGROUND
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PMID: 11253156BACKGROUND
  • Amrock LG, Neuman MD, Lin HM, Deiner S. Can routine preoperative data predict adverse outcomes in the elderly? Development and validation of a simple risk model incorporating a chart-derived frailty score. J Am Coll Surg. 2014 Oct;219(4):684-94. doi: 10.1016/j.jamcollsurg.2014.04.018. Epub 2014 Jun 3.

    PMID: 25154667BACKGROUND
  • Balsam LB. Psoas muscle area: a new standard for frailty assessment in cardiac surgery? J Thorac Dis. 2018 Nov;10(Suppl 33):S3846-S3849. doi: 10.21037/jtd.2018.10.96. No abstract available.

    PMID: 30631495BACKGROUND
  • Wahl TS, Graham LA, Hawn MT, Richman J, Hollis RH, Jones CE, Copeland LA, Burns EA, Itani KM, Morris MS. Association of the Modified Frailty Index With 30-Day Surgical Readmission. JAMA Surg. 2017 Aug 1;152(8):749-757. doi: 10.1001/jamasurg.2017.1025.

    PMID: 28467535BACKGROUND
  • 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.

    BACKGROUND
  • Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546.

    PMID: 26655919BACKGROUND
  • Fukumoto Y, Ikezoe T, Yamada Y, Tsukagoshi R, Nakamura M, Mori N, Kimura M, Ichihashi N. Skeletal muscle quality assessed from echo intensity is associated with muscle strength of middle-aged and elderly persons. Eur J Appl Physiol. 2012 Apr;112(4):1519-25. doi: 10.1007/s00421-011-2099-5. Epub 2011 Aug 17.

    PMID: 21847576BACKGROUND
  • Canales C, Elsayes A, Yeh DD, Belcher D, Nakayama A, McCarthy CM, Chokengarmwong N, Quraishi SA. Nutrition Risk in Critically Ill Versus the Nutritional Risk Screening 2002: Are They Comparable for Assessing Risk of Malnutrition in Critically Ill Patients? JPEN J Parenter Enteral Nutr. 2019 Jan;43(1):81-87. doi: 10.1002/jpen.1181. Epub 2018 May 30.

    PMID: 29846011BACKGROUND
  • Ooi PH, Thompson-Hodgetts S, Pritchard-Wiart L, Gilmour SM, Mager DR. Pediatric Sarcopenia: A Paradigm in the Overall Definition of Malnutrition in Children? JPEN J Parenter Enteral Nutr. 2020 Mar;44(3):407-418. doi: 10.1002/jpen.1681. Epub 2019 Jul 22.

    PMID: 31328301BACKGROUND
  • Joseph B, Pandit V, Zangbar B, Kulvatunyou N, Hashmi A, Green DJ, O'Keeffe T, Tang A, Vercruysse G, Fain MJ, Friese RS, Rhee P. Superiority of frailty over age in predicting outcomes among geriatric trauma patients: a prospective analysis. JAMA Surg. 2014 Aug;149(8):766-72. doi: 10.1001/jamasurg.2014.296.

    PMID: 24920308BACKGROUND
  • Kang S, Oh TJ, Cho BL, Park YS, Roh E, Kim HJ, Lee SG, Kim BJ, Kim M, Won CW, Jang HC. Sex differences in sarcopenia and frailty among community-dwelling Korean older adults with diabetes: The Korean Frailty and Aging Cohort Study. J Diabetes Investig. 2021 Feb;12(2):155-164. doi: 10.1111/jdi.13348. Epub 2020 Aug 8.

    PMID: 32627923BACKGROUND
  • Nguyen HB, Loughead J, Lipner E, Hantsoo L, Kornfield SL, Epperson CN. What has sex got to do with it? The role of hormones in the transgender brain. Neuropsychopharmacology. 2019 Jan;44(1):22-37. doi: 10.1038/s41386-018-0140-7. Epub 2018 Jul 5.

    PMID: 30082887BACKGROUND
  • Pradhananga S, Regmi K, Razzaq N, Ettefaghian A, Dey AB, Hewson D. Ethnic differences in the prevalence of frailty in the United Kingdom assessed using the electronic Frailty Index. Aging Med (Milton). 2019 Sep 13;2(3):168-173. doi: 10.1002/agm2.12083. eCollection 2019 Sep.

    PMID: 31942531BACKGROUND
  • Franse CB, van Grieken A, Qin L, Melis RJF, Rietjens JAC, Raat H. Ethnic differences in frailty: a cross-sectional study of pooled data from community-dwelling older persons in the Netherlands. BMJ Open. 2018 Aug 8;8(8):e022241. doi: 10.1136/bmjopen-2018-022241.

    PMID: 30093521BACKGROUND
  • Griffin FR, Mode NA, Ejiogu N, Zonderman AB, Evans MK. Frailty in a racially and socioeconomically diverse sample of middle-aged Americans in Baltimore. PLoS One. 2018 Apr 10;13(4):e0195637. doi: 10.1371/journal.pone.0195637. eCollection 2018.

    PMID: 29634767BACKGROUND
  • Leffondre K, Abrahamowicz M, Regeasse A, Hawker GA, Badley EM, McCusker J, Belzile E. Statistical measures were proposed for identifying longitudinal patterns of change in quantitative health indicators. J Clin Epidemiol. 2004 Oct;57(10):1049-62. doi: 10.1016/j.jclinepi.2004.02.012.

    PMID: 15528056BACKGROUND

MeSH Terms

Conditions

FrailtySarcopenia

Interventions

UltrasonographySurveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Cecilia Canales, MD, MPH

    UCLA Department of Anesthesiology and Perioperative Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Scovotti, MA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 22, 2021

Study Start

September 22, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The data will not be shared outside the study team.

Locations