Neurophysiological Diagnosis for ICU Septic Shock Patients

ICU Acquired Weakness Clinical Trial

— EDX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03802500
• Other study ID #: NRA-01
• Status: Recruiting
• Start date: January 23, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: CAROLINE ATTWELL
• Phone: 0789242320
• Email: caroline.attwell[@]chuv.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ICU Acquired Weakness
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours.	Medical Research Council strength scale	72 hours
Secondary	ICU length of stay		Up to 6 months
Secondary	Hospital length of stay		Up to 6 months
Secondary	Discharge destination		At discharge from hospital, up to 6 months
Secondary	Length of ventilatory support		At extubation, up to 6 months
Secondary	Extubation failure rate	Patients requiring reintubation 72 hours after failed first extubation	up to 72 hours, after first extubation
Secondary	Time elapsed between endotracheal intubation and first out-of-bed mobilization		up to 6 months, at first out-of-bed mobilization