Effect of Different Electric Muscle Stimulation in Patients With Severe Sepsis and Respiratory Failure

Difference of Muscle Power and Myokine Profile After Upper Limb or Lower Limb Electric Muscle Stimulation in Patients With Severe Sepsis and Acute Respiratory Failure

Rationale : Electric muscle stimulation reduced critical-illness related weakness in patients with severe sepsis and septic shock. But optimal protocol of the stimulation in unknown.

Hypothesis: Focal muscle contraction may improved the muscle power and have systemic anti-inflammatory via cytokine secretion . The difference of electricity used in upper limb or lower limb stimulation may lead to different effect.

Study design: Stratified randomized parallel control study, comparing Biceps, Quadriceps electric muscle stimulation vs. non-stimulation group.

Participant: adult patients with severe sepsis and acute respiratory failure requiring mechanical ventilation.

Intervention: daily stimulation of bilateral Biceps or Quadriceps by programmed electric devices 32 minutes, 5 days/week

Outcome:

1. Primary outcome: Ventilator-dependent days
2. Secondary outcome: change of hand drip muscle power/interleukin-1b/interleukin-6/interleukin-8/TNF-alpha

Study Overview

• Status: Terminated
• Conditions: Inflammation; Severe Sepsis; Acute Respiratory Failure; Muscle Hypotonia; Weakness
• Intervention / Treatment: Device: EMS

Detailed Description

Background : Severe sepsis and septic shock remain top cause of admission to intensive care unit. Muscle weakness was found in 70-100% patients with severe sepsis and septic shock because of critical-illness induced polyneuropathy and myopathy. Previous study revealed electric muscle stimulation (EMS) could reduce such muscle weakness and mechanical ventilator-dependent days.

Hypothesis: different electricity may be needed for minimal contraction of upper or lower limb because of their muscle size. Induced muscle contraction may lead to myokine secretion and beneficial metabolic and anti-inflammatory effect. Stimulation on Quadriceps may be better than on Biceps.

Participant: adult(older than 20 years-old) patients with severe sepsis.septic shock and acute respiratory failure post mechanical ventilation.

Design: Stratified ( gender and age >50 years-old) Randomized parallel 3 arms study.

Intervention: Daily stimulation of Biceps of Quadriceps after third days in intensive care unit. Programmed electric stimulation device ( HELEX 573 model, strength aggressive. mode, 45-55Hz 32 minutes per day, voltage 30-70mA)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• severe sepsis or septic shock patients with acute respiratory failure more than 3 days
• adult patients( age>20 years-old)

Exclusion Criteria:

• skin wound/infection near the site of muscle stimulation
• acute myocardial infarction within 7 days
• pregnant women
• uncontrolled epilepsy
• no spontaneous breath because of central or cervical spinal neuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Biceps stimulation; EMS	Device: EMS; Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes; Other Names: HELEX 573
EXPERIMENTAL: Quadriceps stimulation; EMS	Device: EMS; Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes; Other Names: HELEX 573
NO_INTERVENTION: Control; Control group without electric muscle stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator-dependant Days	Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength Improvement	muscle power measurement by hand grip digital dynamometer every 2 days	21 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Cytokine Change	Serum interleukin(IL)-1B, IL-6, IL-8, IL-10, IL-15 and tumor necrosis factor(TNF)-alpha will be measured before/after first section of EMS, and after fifth EMS section.	First 1 week.

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Investigators: Principal Investigator: Kuang H Cheng, Msc, Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: June 29, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (ESTIMATE): July 10, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: sepsis; respiratory failure; electric muscle stimulation; interleukin 6; interleukin 15
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Systemic Inflammatory Response Syndrome; Neurologic Manifestations; Neuromuscular Manifestations; Sepsis; Toxemia; Inflammation; Respiratory Insufficiency; Respiratory Distress Syndrome; Muscle Hypotonia
• Other Study ID Numbers: 13MMHIS060