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

Study Overview
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Brief Summary
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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: Primary outcome: Ventilator-dependent days Secondary outcome: change of hand drip muscle power/interleukin-1b/interleukin-6/interleukin-8/TNF-alpha

Detailed Description
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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)

Official Title
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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

Conditions
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Severe Sepsis, Acute Respiratory Failure, Muscle Hypotonia, Inflammation, Weakness

Intervention / Treatment
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* Device: EMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biceps stimulation<br>EMS | Device: EMS<br>* Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes<br>* Other names: HELEX 573;|
| Experimental: Quadriceps stimulation<br>EMS | Device: EMS<br>* Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes<br>* Other names: HELEX 573;|
| No Intervention: Control<br>Control group without electric muscle stimulation | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electric muscle stimulation, respiratory failure, sepsis, interleukin 6, interleukin 15