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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765489
• Other study ID #: OAIC 847/16
• Status: Completed
• Phase: N/A
• Start date: November 18, 2016
• Est. completion date: June 21, 2018

Study information

• Verified date: December 2018
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Polyneuropathies
• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	maximum inspiratory pressure	maximum inspiratory pressure	at awakening of the subject, an average of 8 days
Secondary	days of mechanical ventilation	number of days wirh mechanical ventilation	an average of 11 days
Secondary	Number of Participants with weaning failure	Number of Participants who presented reintubation	48 hours post extubation day
Secondary	days of ICU stay	number of days in ICU	at ICU discharge, an average of 18 days
Secondary	mortality at 28 days	mortality	at 28 days post ICU admission
Secondary	gait ability at hospital discharge	presence or not of gait ability	at hospital discharge, an averange of 3 months