Neurophysiological Diagnosis for ICU Septic Shock Patients

• Conditions: ICU Acquired Weakness

• Registration Number: NCT03802500
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-14
• Study Start: 2019-01-23
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-04
• Primary Completion: 2019-10-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours.	72 hours	Medical Research Council strength scale

Secondary Outcome Measures

Name	Time	Method
Discharge destination	At discharge from hospital, up to 6 months
Extubation failure rate	up to 72 hours, after first extubation	Patients requiring reintubation 72 hours after failed first extubation
ICU length of stay	Up to 6 months
Hospital length of stay	Up to 6 months
Time elapsed between endotracheal intubation and first out-of-bed mobilization	up to 6 months, at first out-of-bed mobilization
Length of ventilatory support	At extubation, up to 6 months

Trial Locations

Locations (1)

CHUV; 🇨🇭 Lausanne, Vaud, Switzerland