Clinical trial NCT04550143: Muscle Ultrasound Study in Shock Patients
Official title: Diaphragm Dysfunction and Peripheral Muscle Wasting in Septic Shock Patients: Exploring Their Relationship Over Time Using Ultrasound Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Keywords: Muscle ultrasound
Intensive care unit-acquired weakness
Diaphragm dysfunction
Mechanical ventilation
Weaning
Sepsis
Critical illness
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. pregnancy
2. lower limb amputation, fixators or open wounds
3. thoracic fixators or open wounds
4. diagnosed neuromuscular or central nervous system diseases
5. being transferred from another ICU
6. spinal cord injury
7. diaphragm pacemaker
8. palliative goals of care
9. cancers derived sarcopenia
10. cachexia
11. anorexic disorders (protein-energy malnutrition)
12. intellectual or cognitive impairments, limiting the ability to follow instructions.

Primary outcomes:
measure: Association between SWE assessment and other muscle ultrasound markers.
timeFrame: Baseline (at 24 hours after ICU admission)
measure: Association between SWE assessment and other muscle ultrasound markers.
timeFrame: Day 2, after ICU admission
measure: Association between SWE assessment and other muscle ultrasound markers.
timeFrame: Day 3, after ICU admission
measure: Association between SWE assessment and other muscle ultrasound markers.
timeFrame: Day 4, after ICU admission
measure: Association between SWE assessment and other muscle ultrasound markers.
timeFrame: Day 5, after ICU admission
measure: Association between SWE assessment and other muscle ultrasound markers.
timeFrame: Extubation day, approximately 7 days
measure: Association between SWE assessment and other muscle ultrasound markers.
timeFrame: Weekly (1x/week), counting from day 6 of ICU stay until ICU discharge (approximately 10 days)
measure: Association between SWE assessment and other muscle ultrasound markers.
timeFrame: ICU discharge, approximately 10 days
Secondary outcomes:
measure: Association between the rate change (%) in DUS and PMUS assessments.
timeFrame: Time-points of assessment relating to baseline (ICU admission) values.
measure: Weaning success/failure predictive model.
timeFrame: Between ICU admission and extubation moment.
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Service de Soins Intensifs, Hôpitaux Universitaires de Genève (HUG)
Study officials:
affiliation: Hôpitaux Universitaires de Genève (HUG) / Université de Genève (UNIGE)
name: Karim Bendjelid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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