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

Electrical Muscle Stimulation in the Development of Acquired Weakness in the Intensive Care Unit in Adult Patients With Severe Sepsis and Septic Shock at the Clinic Hospital of the Univerisity of Chile: Results of a Pilot Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock; Muscle Weakness; Polyneuropathies
• Intervention / Treatment: Device: electrical muscle stimulation; Procedure: conventional physical therapy

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Device: electrical muscle stimulation; 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; Procedure: conventional physical therapy; conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al
ACTIVE_COMPARATOR: conventional physical therapy; conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al	Procedure: conventional physical therapy; conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intensive care unit acquired weakness	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	at awakening of the subject, an average of 8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle strength	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).	at awakening of the subject, an average of 8 days
muscle mass	ultrasonography	at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days
maximum inspiratory pressure	maximum inspiratory pressure	at awakening of the subject, an average of 8 days
days of mechanical ventilation	number of days wirh mechanical ventilation	an average of 11 days
Number of Participants with weaning failure	Number of Participants who presented reintubation	48 hours post extubation day
days of ICU stay	number of days in ICU	at ICU discharge, an average of 18 days
mortality at 28 days	mortality	at 28 days post ICU admission
gait ability at hospital discharge	presence or not of gait ability	at hospital discharge, an averange of 3 months

Collaborators and Investigators

• Sponsor: University of Chile

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 18, 2016
• Primary Completion (ACTUAL): June 21, 2018
• Study Completion (ACTUAL): June 21, 2018

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (ACTUAL): December 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: intensive care unit; muscle weakness; septic shock; electrical stimulation; sepsis; polyneuropathies
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuromuscular Manifestations; Sepsis; Shock, Septic; Muscle Weakness; Shock; Polyneuropathies; Paresis; Asthenia
• Other Study ID Numbers: OAIC 847/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes