Neurophysiological Diagnosis for ICU Septic Shock Patients

NCT03802500 | Unknown

• 1 other identifier: NRA-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

ICU Acquired Weakness

Outcome Measures

Primary Outcomes (1)

• Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours.

  Medical Research Council strength scale

  72 hours

Secondary Outcomes (6)

• 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

  up to 72 hours, after first extubation

Interventions

Nerve conduction study DIAGNOSTIC_TEST

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.

Also known as: Peroneal nerve test (PENT test)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1000, Switzerland

RECRUITING

MeSH Terms

Interventions

Nerve Conduction Studies

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Karin Diserens, PD-MER

  NRA Unit. CHUV.

  STUDY DIRECTOR

Central Study Contacts

CAROLINE ATTWELL

CONTACT

0789242320; caroline.attwell@chuv.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: January 14, 2019
• Study Start: January 23, 2019
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)