Clinical trial NCT03802500: Neurophysiological Diagnosis for ICU Septic Shock Patients
Official title: Early Electromyographic Evaluation of the ICU-acquired Weakness in Septic Shock Patients Ventilated Longer Than 72 Hours: Neurophysiological Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ICU Acquired Weakness
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours.
timeFrame: 72 hours
Secondary outcomes:
measure: ICU length of stay
timeFrame: Up to 6 months
measure: Hospital length of stay
timeFrame: Up to 6 months
measure: Discharge destination
timeFrame: At discharge from hospital, up to 6 months
measure: Length of ventilatory support
timeFrame: At extubation, up to 6 months
measure: Extubation failure rate
timeFrame: up to 72 hours, after first extubation
measure: Time elapsed between endotracheal intubation and first out-of-bed mobilization
timeFrame: up to 6 months, at first out-of-bed mobilization
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
affiliation: NRA Unit. CHUV.
name: Karin Diserens, PD-MER
role: STUDY_DIRECTOR
References: