NCT05572138

Brief Summary

The aim of the study is to detect a value of muscle and organ mass measured by body impedance analysis and its correlation with the Medical Research Council (MRC) score. An MRC score ≤ 48 is defined as a diagnosis of ICU acquired weakness. The correlation of the values detected by BIA and their transfer to an MRC Score ≤ 48 will be investigated. The knowledge gained will be used for early detection of ICUAW in order to reduce the consequences of the same.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

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

First Submitted

Initial submission to the registry

October 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 8, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

October 5, 2022

Last Update Submit

February 3, 2024

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • Correlation: Skeletal muscle mass and MRC-Score

    The primary endpoint is the correlation between Skeletal muscle mass (SMM) measured by BIA and MRC score.

    till Day 30

Secondary Outcomes (10)

  • Correlation CSA and Skeletal muscle mass

    till Day 30

  • UCR : MRC correlation

    till Day 30

  • Kreatinin : MRC correlation

    till Day 30

  • IMS during the ICU stay

    till Day 30 or ICU discharge

  • ICU mortality

    till Day 30

  • +5 more secondary outcomes

Study Arms (1)

Critically ill patients

Diagnostic Test: Body Impedance Analysis

Interventions

Body Impedance AnalysisDIAGNOSTIC_TEST

Body Impedance Analysis

Critically ill patients

Eligibility Criteria

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

critically ill invasively ventilated patients

You may qualify if:

  • \- Patients aged ≥ 18 years with ventilatory support within 36 hours from ICU admission.

You may not qualify if:

  • With a language barrier
  • Patients with pacemaker or other electronic implant
  • Expected death or discontinuation of life-sustaining measures.
  • Not walking independently before hospitalization (gait aids allowed)
  • Allergy to electrode gel
  • BIA or ultrasound not technically feasible due to e.g. extensive wounds, skin rash or bandages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Univiversitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (10)

  • Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004.

    PMID: 15380917BACKGROUND

  • Savalle M, Gillaizeau F, Maruani G, Puymirat E, Bellenfant F, Houillier P, Fagon JY, Faisy C. Assessment of body cell mass at bedside in critically ill patients. Am J Physiol Endocrinol Metab. 2012 Aug 1;303(3):E389-96. doi: 10.1152/ajpendo.00502.2011. Epub 2012 May 29.

    PMID: 22649067BACKGROUND

  • Fan E, Cheek F, Chlan L, Gosselink R, Hart N, Herridge MS, Hopkins RO, Hough CL, Kress JP, Latronico N, Moss M, Needham DM, Rich MM, Stevens RD, Wilson KC, Winkelman C, Zochodne DW, Ali NA; ATS Committee on ICU-acquired Weakness in Adults; American Thoracic Society. An official American Thoracic Society Clinical Practice guideline: the diagnosis of intensive care unit-acquired weakness in adults. Am J Respir Crit Care Med. 2014 Dec 15;190(12):1437-46. doi: 10.1164/rccm.201411-2011ST.

    PMID: 25496103BACKGROUND

  • Appleton RT, Kinsella J, Quasim T. The incidence of intensive care unit-acquired weakness syndromes: A systematic review. J Intensive Care Soc. 2015 May;16(2):126-136. doi: 10.1177/1751143714563016. Epub 2014 Dec 18.

    PMID: 28979394BACKGROUND

  • Van Aerde N, Meersseman P, Debaveye Y, Wilmer A, Gunst J, Casaer MP, Bruyninckx F, Wouters PJ, Gosselink R, Van den Berghe G, Hermans G. Five-year impact of ICU-acquired neuromuscular complications: a prospective, observational study. Intensive Care Med. 2020 Jun;46(6):1184-1193. doi: 10.1007/s00134-020-05927-5. Epub 2020 Jan 22.

    PMID: 31970446BACKGROUND

  • Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

    PMID: 24108501BACKGROUND

  • Wollersheim T, Woehlecke J, Krebs M, Hamati J, Lodka D, Luther-Schroeder A, Langhans C, Haas K, Radtke T, Kleber C, Spies C, Labeit S, Schuelke M, Spuler S, Spranger J, Weber-Carstens S, Fielitz J. Dynamics of myosin degradation in intensive care unit-acquired weakness during severe critical illness. Intensive Care Med. 2014 Apr;40(4):528-38. doi: 10.1007/s00134-014-3224-9. Epub 2014 Feb 15.

    PMID: 24531339BACKGROUND

  • Hough CL, Lieu BK, Caldwell ES. Manual muscle strength testing of critically ill patients: feasibility and interobserver agreement. Crit Care. 2011;15(1):R43. doi: 10.1186/cc10005. Epub 2011 Jan 28.

    PMID: 21276225BACKGROUND

  • Gijsen M, Simons E, De Cock P, L N G Malbrain M, Wauters J, Spriet I. Reproducibility of fluid status measured by bioelectrical impedance analysis in healthy volunteers: a key requirement to monitor fluid status in the intensive care unit. Anaesthesiol Intensive Ther. 2021;53(3):193-199. doi: 10.5114/ait.2021.105826.

    PMID: 34284553BACKGROUND

  • De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.

    PMID: 12472328BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan J Schaller, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Clinical Director

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 7, 2022

Study Start

February 8, 2023

Primary Completion

January 28, 2024

Study Completion

January 28, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

DE(1)