Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock

Not Applicable

Completed

• Conditions: Septic Shock; Polyneuropathies; Muscle Weakness
• Interventions: Procedure: conventional physical therapy; Device: electrical muscle stimulation

• Registration Number: NCT03765489
• Lead Sponsor: University of Chile

Brief Summary

The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.

Detailed Description

Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.

Study Timeline

• Study Start: 2016-11-18
• Primary Completion: 2018-06-21
• Study Completion: 2018-06-21
• Study First Submitted: 2018-11-12
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-03
• Last Update Submitted: 2018-12-03
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Subjects admitted to the ICU of the HCUCH in the period between November 2016 to August 2017 and January to June 2018
• Diagnosis of severe sepsis or septic shock
• More than 48 hours in VMI
• With sedation and / or neuromuscular blockade
• Autovalent prior to admission to the ICU

Exclusion Criteria

• Subjects from other hospitals / clinics or units of the hospital
• Multiple trauma
• Previous neuromuscular pathology
• Pacemaker users
• Pregnant women
• BMI> 35
• Epilepsy
• Those who have refused to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional physical therapy	conventional physical therapy	conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al
electrical muscle stimulation	conventional physical therapy	conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction
electrical muscle stimulation	electrical muscle stimulation	conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction

Primary Outcome Measures

Name	Time	Method
intensive care unit acquired weakness	at awakening of the subject, an average of 8 days	Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness

Secondary Outcome Measures

Name	Time	Method
muscle mass	at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days	ultrasonography
days of ICU stay	at ICU discharge, an average of 18 days	number of days in ICU
mortality at 28 days	at 28 days post ICU admission	mortality
muscle strength	at awakening of the subject, an average of 8 days	Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength).
maximum inspiratory pressure	at awakening of the subject, an average of 8 days	maximum inspiratory pressure
days of mechanical ventilation	an average of 11 days	number of days wirh mechanical ventilation
Number of Participants with weaning failure	48 hours post extubation day	Number of Participants who presented reintubation
gait ability at hospital discharge	at hospital discharge, an averange of 3 months	presence or not of gait ability