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Clinical Trials/NCT04550143
NCT04550143
Completed
Not Applicable

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

University Hospital, Geneva1 site in 1 country30 target enrollmentOctober 13, 2020
ConditionsSeptic Shock

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Septic Shock
Sponsor
University Hospital, Geneva
Enrollment
30
Locations
1
Primary Endpoint
Association between SWE assessment and other muscle ultrasound markers.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 13, 2020
End Date
August 20, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karim Bendjelid

Professor

University Hospital, Geneva

Eligibility Criteria

Inclusion Criteria

  • 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;

Exclusion Criteria

  • 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
  • diaphragm pacemaker
  • palliative goals of care
  • cancers derived sarcopenia
  • anorexic disorders (protein-energy malnutrition)
  • intellectual or cognitive impairments, limiting the ability to follow instructions.

Outcomes

Primary Outcomes

Association between SWE assessment and other muscle ultrasound markers.

Time Frame: ICU discharge, approximately 10 days

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.

Secondary Outcomes

  • Association between the rate change (%) in DUS and PMUS assessments.(Time-points of assessment relating to baseline (ICU admission) values.)
  • Weaning success/failure predictive model.(Between ICU admission and extubation moment.)

Study Sites (1)

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