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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-09-30

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:

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

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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)

Conditions

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Severe Sepsis Acute Respiratory Failure Muscle Hypotonia Inflammation Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Biceps stimulation

EMS

Group Type EXPERIMENTAL

EMS

Intervention Type DEVICE

Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes

Quadriceps stimulation

EMS

Group Type EXPERIMENTAL

EMS

Intervention Type DEVICE

Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes

Control

Control group without electric muscle stimulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EMS

Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes

Intervention Type DEVICE

Other Intervention Names

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HELEX 573

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No