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

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ClinicalTrials.gov Identifier: NCT01895647
Recruitment Status : Terminated (slow recruitment and high drop-out rate)
First Posted : July 10, 2013
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Condition or disease Intervention/treatment
Severe Sepsis Acute Respiratory Failure Muscle Hypotonia Inflammation Weakness 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2013
Primary Completion Date : September 2015
Study Completion Date : September 2015


Arms and Interventions

Arm Intervention/treatment
Experimental: Biceps stimulation
EMS
Device: EMS
Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
Other Name: HELEX 573
Experimental: Quadriceps stimulation
EMS
Device: EMS
Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
Other Name: HELEX 573
No Intervention: Control
Control group without electric muscle stimulation


Outcome Measures

Primary Outcome Measures :
  1. ventilator-dependant days [ Time Frame: 21 days ]
    Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)


Secondary Outcome Measures :
  1. Muscle strength improvement [ Time Frame: 21 days ]
    muscle power measurement by hand grip digital dynamometer every 2 days


Other Outcome Measures:
  1. Inflammatory cytokine change [ Time Frame: First 1 week. ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895647


Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan, 10449
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Kuang H Cheng, Msc Mackay Memorial Hospital
More Information

Responsible Party: Kuang-Hua Cheng, MD, visiting staff of pulmonary medicine, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01895647     History of Changes
Other Study ID Numbers: 13MMHIS060
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by Kuang-Hua Cheng, MD, Mackay Memorial Hospital:
electric muscle stimulation
respiratory failure
sepsis
interleukin 6
interleukin 15

Additional relevant MeSH terms:
Inflammation
Sepsis
Toxemia
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Muscle Hypotonia
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms