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Septic ShockMUSiShockNCT04550143

Muscle Ultrasound Study in Shock Patients

An observational study of Septic Shock, run by University Hospital, Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Intensive Care Unit (ICU) patients are known to lose muscle mass and function for many reasons, ranging from prolonged immobilization, to the effects of ICU treatments such as mechanical ventilation (MV), to the critical illness itself. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock
What is being tested?
Diaphragm ultrasound (DUS), Peripheral Muscle Ultrasound (PMUS) and Airway occlusion pressure (P0.1)
How many people
30 participants
Where
1 siteSwitzerland
Study dates
13 Oct 2020to 20 Aug 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This research project will include any adult patient (> 18 years old) admitted to the ICU (University Hospitals of Geneva, HUG) with a diagnosis of septic shock, respecting the pre-defined inclusion and exclusion criteria. No restrictions will be applied to the source of infection.

Who may be able to join

  • adult patients (> 18 years old) admitted to the ICU
  • with a diagnosis of septic shock
  • a SOFA score equal or superior to 8 points, at ICU admission
  • blood lactate concentration above 2 mmol/L, at ICU admission
  • expected to have more than 48h of mechanical ventilation (estimated by the attending physician)
  • expected to stay more than 5 days in the unit (estimated by the attending physician)
  • able to walk prior to ICU admission / walking aids accepted;

Who cannot join

  • pregnancy
  • lower limb amputation, fixators or open wounds
  • thoracic fixators or open wounds
  • diagnosed neuromuscular or central nervous system diseases
  • being transferred from another ICU
  • spinal cord injury
Show all 12Show fewer
  • diaphragm pacemaker
  • palliative goals of care
  • cancers derived sarcopenia
  • cachexia
  • anorexic disorders (protein-energy malnutrition)
  • intellectual or cognitive impairments, limiting the ability to follow instructions.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Service de Soins Intensifs, Hôpitaux Universitaires de Genève (HUG)

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: Diaphragm Dysfunction and Peripheral Muscle Wasting in Septic Shock Patients: Exploring Their Relationship Over Time Using Ultrasound Technology

Intensive Care Unit (ICU) patients are known to lose muscle mass and function for many reasons, ranging from prolonged immobilization, to the effects of ICU treatments such as mechanical ventilation (MV), to the critical illness itself. Ultrasonography (US) is widely used in the ICU setting and has greatly evolved in the last decades, since it allows the non-invasive assessment of different structures, using radiation-free and user-friendly technology; its application for the assessment or the skeletal muscle is a promising tool and might help detecting muscle changes and thus several dysfunctions during early stages of ICU stay.

By using skeletal muscle ultrasound at both diaphragm and peripheral levels, the overall aim of this study is to improve knowledge in the early detection of muscle dysfunction and weakness , and their relationship with mechanical ventilation weaning and muscle strength, in critically ill patients suffering from septic shock.

Conditions
Septic Shock
Being tested
Diaphragm ultrasound (DUS), Peripheral Muscle Ultrasound (PMUS), Airway occlusion pressure (P0.1), Medical Research Council (MRC) sum score
Keywords
Muscle ultrasound, Intensive care unit-acquired weakness, Diaphragm dysfunction, Mechanical ventilation, Weaning, Sepsis, Critical illness
Medical subject headings
Shock, Septic, Sepsis, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diaphragm ultrasound (DUS)Other

    Also called Diaphragm ultrasonography

    DUS assessments of diaphragmatic thickness (TDI), thickness fraction (TFDI) and shear modulus (SMDI), this last measured by shear-wave elastography (SWE), will be performed for both right and left hemi-diaphragms.

    A landmark between the 8th and 10th intercostal space in the mid-axillary or antero-axillary line, 0.5-2 cm below the costophrenic sinus, will be used. Here, the diaphragm can be seen as the less echogenic structure between two echogenic lines; TDI (cm) will be the calculated as the distance between the two lines at the end of expiration and TFDI as the rate of change between end-expiration and end-inspiration thicknesses (TFDI = "thickness at end inspiration" - "thickness at end-expiration" / "thickness at end-expiration", %).

    SMDI will assess muscle's stiffness. For each image, a region of interest covering the widest possible surface of diaphragm and allowing an acquisition frequency of 2Hz will be set; results will be retrieved in kilopascals (kPa).

  • Peripheral Muscle Ultrasound (PMUS)Other

    Also called Muscle ultrasonography

    PMUS assessments of quadriceps rectus femoris (RF) muscle cross-sectional area (CSARF), echogenicity (ECHORF) and shear modulus (SMRF), this last measured by shear-wave elastography (SWE), will be performed.

    Probe will be placed perpendicularly to the anterior plane of the thigh, in 2 anatomical points, as follows:

    (i) in the midpoint between the anterior superior iliac spine and the upper pole of the patella and (ii) the border of the lower 1/3 and upper 2/3 between the anterior superior iliac spine and the upper pole of the patella.

    CSARF (cm2) will be calculated by outlining the area under the muscle hyperechoic line (aponeurosis). For ECHORF (differences in grey-scale images), the analysis of a region of interest (ROI) of 2cm x 2cm will be performed.

    For SMRF (kPa), a ROI covering the widest possible area of the RF and allowing an acquisition frequency of 2Hz will be set for analysis.

    All assessments will be performed with minimal compression and a copious amount of water-gel.

  • Airway occlusion pressure (P0.1)Other

    P0.1 is "the pressure developed in the occluded airway 100 milliseconds after the onset of inspiration". Its use doesn't require any additional equipment since it can be easy measured by using patient's ventilator.

    For the measurement itself, patients will be in semi-recumbent position (head elevation between 30° and 45°) with knee extended in neutral position and will be asked to stay as relaxed as possible. After 5 minutes breathing without any interruption or disturbance, 4 measurements will be observed and recorded as displayed on the ventilator screen.

  • Medical Research Council (MRC) sum scoreOther

    Also called MRC muscle strength score

    This is a manual muscle strength testing tool, used very often in the ICU setting. It's based on the assessment of the following muscle groups: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and dorsiflexion of the ankle, all scored bilaterally. Muscle strength is graded as follows: 0, "no visible/palpable contraction"; 1, "visible/palpable contraction without movement of the limb"; 2, "movement of the limb, but not against gravity"; 3, "movement against gravity"; 4, "movement against gravity and some resistance"; 5, "normal".

    The sum score ranges between 0 and 60 (between 0 and 5, in 12 muscle groups), with a score <48 indicating the presence of weakness.

Study groups in NCT04550143
Study groupRoleWhat they receive
Septic ShockNot described
Receives: Other: Diaphragm ultrasound (DUS); Other: Peripheral Muscle Ultrasound (PMUS); Other: Airway occlusion pressure (P0.1); Other: Medical Research Council (MRC) sum score

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association between SWE assessment and other muscle ultrasound markers.

    To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.

    Measured: Baseline (at 24 hours after ICU admission)

  2. Association between SWE assessment and other muscle ultrasound markers.

    To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.

    Measured: Day 2, after ICU admission

  3. Association between SWE assessment and other muscle ultrasound markers.

    To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.

    Measured: Day 3, after ICU admission

  4. Association between SWE assessment and other muscle ultrasound markers.

    To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.

    Measured: Day 4, after ICU admission

  5. Association between SWE assessment and other muscle ultrasound markers.

    To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.

    Measured: Day 5, after ICU admission

  6. Association between SWE assessment and other muscle ultrasound markers.

    To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.

    Measured: Extubation day, approximately 7 days

  7. Association between SWE assessment and other muscle ultrasound markers.

    To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.

    Measured: Weekly (1x/week), counting from day 6 of ICU stay until ICU discharge (approximately 10 days)

  8. Association between SWE assessment and other muscle ultrasound markers.

    To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.

    Measured: ICU discharge, approximately 10 days

Secondary outcomes (2)

  1. Association between the rate change (%) in DUS and PMUS assessments.

    The association between the rate change (%) in DUS (TDI, TFDI and SMDI) and PMUS (CSARF, ECHORF and SMRF) markers over time, during the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.

    Measured: Time-points of assessment relating to baseline (ICU admission) values.

  2. Weaning success/failure predictive model.

    The analysis of a combined model comprising, among other ICU variables, one DUS marker (TDI, TFDI and SMDI) and one PMUS marker (CSARF, ECHORF and SMRF) to predict weaning success/failure, in adult patients (> 18 years old) admitted to the ICU for a septic shock.

    Measured: Between ICU admission and extubation moment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start13 Oct 2020
  3. Primary completion20 Aug 2024
  4. Study completion20 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04550143
Sponsor's protocol ID
2020-00452
Acronym
MUSiShock
Status last verified
Dec 2024
First submitted
31 Aug 2020
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.

    PubMed 20813887

  • Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.

    PubMed 28930478

  • 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.

    PubMed 24108501

  • 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.

    PubMed 25882765

  • Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.

    PubMed 27310484

  • Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.

    PubMed 26167730

  • Bachasson D, Dres M, Nierat MC, Gennisson JL, Hogrel JY, Doorduin J, Similowski T. Diaphragm shear modulus reflects transdiaphragmatic pressure during isovolumetric inspiratory efforts and ventilation against inspiratory loading. J Appl Physiol (1985). 2019 Mar 1;126(3):699-707. doi: 10.1152/japplphysiol.01060.2018. Epub 2019 Feb 7.

    PubMed 30730816

  • Flatres A, Aarab Y, Nougaret S, Garnier F, Larcher R, Amalric M, Klouche K, Etienne P, Subra G, Jaber S, Molinari N, Matecki S, Jung B. Real-time shear wave ultrasound elastography: a new tool for the evaluation of diaphragm and limb muscle stiffness in critically ill patients. Crit Care. 2020 Feb 3;24(1):34. doi: 10.1186/s13054-020-2745-6.

    PubMed 32014005

  • Quenot JP, Binquet C, Kara F, Martinet O, Ganster F, Navellou JC, Castelain V, Barraud D, Cousson J, Louis G, Perez P, Kuteifan K, Noirot A, Badie J, Mezher C, Lessire H, Pavon A. The epidemiology of septic shock in French intensive care units: the prospective multicenter cohort EPISS study. Crit Care. 2013 Apr 25;17(2):R65. doi: 10.1186/cc12598.

    PubMed 23561510

  • SepNet Critical Care Trials Group. Incidence of severe sepsis and septic shock in German intensive care units: the prospective, multicentre INSEP study. Intensive Care Med. 2016 Dec;42(12):1980-1989. doi: 10.1007/s00134-016-4504-3. Epub 2016 Sep 29.

    PubMed 27686355

  • Neto Silva I, Duarte JA, Perret A, Dousse N, Wozniak H, Bollen Pinto B, Giraud R, Bendjelid K. Diaphragm dysfunction and peripheral muscle wasting in septic shock patients: Exploring their relationship over time using ultrasound technology (the MUSiShock protocol). PLoS One. 2022 Mar 28;17(3):e0266174. doi: 10.1371/journal.pone.0266174. eCollection 2022.

    PubMed 35344570

Questions about this trial

What is this clinical trial studying?

An observational study of Septic Shock, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association between SWE assessment and other muscle ultrasound markers. (time frame: Baseline (at 24 hours after ICU admission)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04550143, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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