Neurophysiological Diagnosis for ICU Septic Shock Patients (EDX)

Early Electromyographic Evaluation of the ICU-acquired Weakness in Septic Shock Patients Ventilated Longer Than 72 Hours: Neurophysiological Study

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.

Study Overview

• Status: Unknown
• Conditions: ICU Acquired Weakness
• Intervention / Treatment: Diagnostic test: Nerve conduction study

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: CAROLINE ATTWELL; Phone Number: 0789242320; Email: caroline.attwell@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Recruiting
      • CHUV
      • Contact: CAROLINE ATTWELL; Phone Number: 0795567994; Email: caroline.attwell@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours.	Medical Research Council strength scale	72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Study Director: Karin Diserens, PD-MER, NRA Unit. CHUV.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2019
• Primary Completion (ANTICIPATED): October 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (ACTUAL): January 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Asthenia
• Other Study ID Numbers: NRA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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