NCT03717831

Brief Summary

Patients surviving critical illness suffered significant skeletal muscle dysfunction and weakness that impacts their functionality and independence. The primary purpose of this project is to develop a classification system based on the health and function of the muscle at very early time points during critical illness. The investigators will determine if muscle ultrasound can predict functional recovery at six-months post hospital discharge. Researchers will assess muscle health and function from starting day one of admission to ICU and continue until six months of recovery. In addition to muscle ultrasound, the investigators will assess muscle strength and power, and perform muscle tissue analysis on a subset of individuals. These findings will be correlated to physical function and independence at six-month follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 17, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

October 22, 2018

Last Update Submit

January 29, 2020

Conditions

Critical IllnessIntensive Care (ICU) MyopathyPICSMuscle Weakness

Keywords

muscle ultrasoundpost-intensive care syndromephysical functionmuscle tissue analysis

Outcome Measures

Primary Outcomes (1)

  • Physical function

    Gait speed measured with 4 meter (Short Performance Physical Battery)

    6 month follow-up

Secondary Outcomes (1)

  • Capacity for physical activity/exercise

    6 month follow-up

Study Arms (2)

Healthy

Healthy subjects will be enrolled as age and activity matched controls for muscle power assessment at one time-point to establish normative values.

Other: Observational study of standard of care

ICU

Observational, subjects enrolled initially in the ICU and followed for six months after hospital discharge. ICU subdivided based on diagnosis

Other: Observational study of standard of care

Interventions

Observational study of standard of careOTHER

Observational cohort study

HealthyICU

Eligibility Criteria

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

Adult patients admitted to ICU for critical illness with diagnosis of acute respiratory failure will be enrolled in this observational study.

You may qualify if:

  • admitted to medicine, cardio-thoracic or trauma ICU
  • initial primary or secondary diagnosis of acute respiratory distress/failure
  • mechanical ventilation (predicted for at-least 72 hours)

You may not qualify if:

  • receiving palliative treatment
  • attending physician excluding due to high-risk of mortality
  • neurological injury or event
  • lower extremity amputee
  • pregnant
  • non-ambulatory prior to admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (9)

  • Bienvenu OJ, Colantuoni E, Mendez-Tellez PA, Dinglas VD, Shanholtz C, Husain N, Dennison CR, Herridge MS, Pronovost PJ, Needham DM. Depressive symptoms and impaired physical function after acute lung injury: a 2-year longitudinal study. Am J Respir Crit Care Med. 2012 Mar 1;185(5):517-24. doi: 10.1164/rccm.201103-0503OC. Epub 2011 Dec 8.

    PMID: 22161158RESULT

  • Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.

    PMID: 24247473RESULT

  • Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

    PMID: 21470008RESULT

  • Yang T, Li Z, Jiang L, Wang Y, Xi X. Risk factors for intensive care unit-acquired weakness: A systematic review and meta-analysis. Acta Neurol Scand. 2018 Aug;138(2):104-114. doi: 10.1111/ane.12964. Epub 2018 May 29.

    PMID: 29845614RESULT

  • Rawal G, Yadav S, Kumar R. Post-intensive Care Syndrome: an Overview. J Transl Int Med. 2017 Jun 30;5(2):90-92. doi: 10.1515/jtim-2016-0016. eCollection 2017 Jun.

    PMID: 28721340RESULT

  • Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

    PMID: 19446324RESULT

  • Morris PE, Berry MJ, Files DC, Thompson JC, Hauser J, Flores L, Dhar S, Chmelo E, Lovato J, Case LD, Bakhru RN, Sarwal A, Parry SM, Campbell P, Mote A, Winkelman C, Hite RD, Nicklas B, Chatterjee A, Young MP. Standardized Rehabilitation and Hospital Length of Stay Among Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2016 Jun 28;315(24):2694-702. doi: 10.1001/jama.2016.7201.

    PMID: 27367766RESULT

  • Puthucheary ZA, Phadke R, Rawal J, McPhail MJ, Sidhu PS, Rowlerson A, Moxham J, Harridge S, Hart N, Montgomery HE. Qualitative Ultrasound in Acute Critical Illness Muscle Wasting. Crit Care Med. 2015 Aug;43(8):1603-11. doi: 10.1097/CCM.0000000000001016.

    PMID: 25882765RESULT

  • Dos Santos C, Hussain SN, Mathur S, Picard M, Herridge M, Correa J, Bain A, Guo Y, Advani A, Advani SL, Tomlinson G, Katzberg H, Streutker CJ, Cameron JI, Schols A, Gosker HR, Batt J; MEND ICU Group; RECOVER Program Investigators; Canadian Critical Care Translational Biology Group. Mechanisms of Chronic Muscle Wasting and Dysfunction after an Intensive Care Unit Stay. A Pilot Study. Am J Respir Crit Care Med. 2016 Oct 1;194(7):821-830. doi: 10.1164/rccm.201512-2344OC.

    PMID: 27058306RESULT

MeSH Terms

Conditions

Critical IllnessMuscular DiseasesMuscle Weaknesspostintensive care syndrome

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesNeuromuscular ManifestationsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Kirby Mayer, DPT, PhD(c)

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Research Assistant

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

October 17, 2018

Primary Completion

July 1, 2019

Study Completion

July 15, 2019

Last Updated

January 31, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)