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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):
Kuang-Hua Cheng, MD, Mackay Memorial Hospital

June 29, 2013
July 10, 2013
November 8, 2016
June 2013
September 2015   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01895647 on ClinicalTrials.gov Archive Site
Muscle strength improvement [ Time Frame: 21 days ]
muscle power measurement by hand grip digital dynamometer every 2 days
Same as current
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.
Same as current
 
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

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)

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Severe Sepsis
  • Acute Respiratory Failure
  • Muscle Hypotonia
  • Inflammation
  • Weakness
Device: EMS
Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
Other Name: HELEX 573
  • Experimental: Biceps stimulation
    EMS
    Intervention: Device: EMS
  • Experimental: Quadriceps stimulation
    EMS
    Intervention: Device: EMS
  • No Intervention: Control
    Control group without electric muscle stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
150
September 2015
September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01895647
13MMHIS060
No
Not Provided
Not Provided
Kuang-Hua Cheng, MD, Mackay Memorial Hospital
Mackay Memorial Hospital
Not Provided
Principal Investigator: Kuang H Cheng, Msc Mackay Memorial Hospital
Mackay Memorial Hospital
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP