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Neurophysiological Diagnosis for ICU Septic Shock Patients (EDX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03802500
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : October 4, 2019
Information provided by (Responsible Party):
CAROLINE ATTWELL, Centre Hospitalier Universitaire Vaudois

Brief Summary:

Patients hospitalized in the Intensive Care Unit (ICU) are at risk for developing severe disabilities, physical or cognitive. In particular, ICU-acquired weakness is frequent. The causes of this weakness are multiple and the physiopathology is still not fully understood. Immobilization in bed and sepsis are known risk factors.

ICU-acquired weakness has been associated with prolonged mechanical ventilation duration, and increased in ICU and hospital length of stay. It has also been associated with significant decrease in functional capacity and with higher mortality. An early screening using a specific diagnostic protocol could help improving the management of patients suffering from ICU acquired weakness.

The aim of this study is to early detect ICU acquired weakness in patients suffering from septic shock and ventilated for more than 72 hours.

Condition or disease Intervention/treatment
ICU Acquired Weakness Diagnostic Test: Nerve conduction study

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Electromyographic Evaluation of the ICU-acquired Weakness in Septic Shock Patients Ventilated Longer Than 72 Hours: Neurophysiological Study
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Intervention Details:
  • Diagnostic Test: Nerve conduction study

    Physical examination of muscle strength is conducted using the Medical Research Council (MRC) scale in 6 muscles bilaterally.

    Patients with an MRC score of less than 48 of 60 are diagnosed with critical illness polyneuromyopathy (CIPNM).

    The evaluation is completed by a routine neurological examination. In patients meeting the inclusion criteria, the screening Peroneal nerve test (PENT test) is performed on the day of study enrollment and subsequently in 1 week intervals until pathologic findings are detected or patient is discharged from the ICU.

    PENT measures the peroneal nerve Compound muscle action potential (CMAP) amplitude in one leg. If the PENT is normal, the contra-lateral peroneal nerve is measured. An abnormal condition is identified if the peroneal nerve CMAP amplitude is reduced below the normal limits of the participating centre in at least one leg. In Lausanne, the abnormal response is < 2,5 mV.

    Other Name: Peroneal nerve test (PENT test)

Primary Outcome Measures :
  1. Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours. [ Time Frame: 72 hours ]
    Medical Research Council strength scale

Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: Up to 6 months ]
  2. Hospital length of stay [ Time Frame: Up to 6 months ]
  3. Discharge destination [ Time Frame: At discharge from hospital, up to 6 months ]
  4. Length of ventilatory support [ Time Frame: At extubation, up to 6 months ]
  5. Extubation failure rate [ Time Frame: up to 72 hours, after first extubation ]
    Patients requiring reintubation 72 hours after failed first extubation

  6. Time elapsed between endotracheal intubation and first out-of-bed mobilization [ Time Frame: up to 6 months, at first out-of-bed mobilization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.

Inclusion Criteria:

• Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.

Exclusion Criteria:

  • Hospitalization for more than 7 days before intubation.
  • Functional disability at admission of ≥4 (Requires constant nursing care and attention, bedridden, incontinent) in the Modified Rankin Scale.
  • Lower limb disorders precluding nerve conduction studies (NCV) and electromyography (EMG), such as clinical edema of the lower limbs, or fractures, amputation, and plaster casts of the lower limbs.
  • Evidence of altered neuromuscular transmission at repetitive stimulation test either caused by neuromuscular blocking agents or disease.
  • Burn patients admitted to ICU.
  • Patient requesting withdrawal of therapies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03802500

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Contact: CAROLINE ATTWELL 0789242320

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CHUV Recruiting
Lausanne, Vaud, Switzerland, 1000
Contact: CAROLINE ATTWELL    0795567994   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
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Study Director: Karin Diserens, PD-MER NRA Unit. CHUV.
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Responsible Party: CAROLINE ATTWELL, Mrs, Centre Hospitalier Universitaire Vaudois Identifier: NCT03802500    
Other Study ID Numbers: NRA-01
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes