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

NCT03765489 | Completed FDA Device

• 1 other identifier: OAIC 847/16
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polyneuropathies; Septic Shock; Muscle Weakness

Keywords

polyneuropathies; muscle weakness; sepsis; septic shock; electrical stimulation; intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• muscle strength

  at awakening of the subject, an average of 8 days

• muscle mass

  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

  at awakening of the subject, an average of 8 days

• days of mechanical ventilation

  an average of 11 days

• Number of Participants with weaning failure

  48 hours post extubation day

Study Arms (2)

electrical muscle stimulation

EXPERIMENTAL

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; Procedure: conventional physical therapy

conventional physical therapy

ACTIVE COMPARATOR

conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al

Procedure: conventional physical therapy

Interventions

electrical muscle stimulation DEVICE

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

conventional physical therapy PROCEDURE

conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al

conventional physical therapy; electrical muscle stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead

MeSH Terms

Conditions

Polyneuropathies; Shock, Septic; Muscle Weakness; Sepsis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: December 5, 2018
• Study Start: November 18, 2016
• Primary Completion: June 21, 2018
• Study Completion: June 21, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12