Effect of Different Electric Muscle Stimulation in Patients With Severe Sepsis and Respiratory Failure
Primary Purpose
Severe Sepsis, Acute Respiratory Failure, Muscle Hypotonia
Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
EMS
Sponsored by
About this trial
This is an interventional prevention trial for Severe Sepsis focused on measuring electric muscle stimulation, respiratory failure, sepsis, interleukin 6, interleukin 15
Eligibility 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
Sites / Locations
- Mackay Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Biceps stimulation
Quadriceps stimulation
Control
Arm Description
EMS
EMS
Control group without electric muscle stimulation
Outcomes
Primary Outcome Measures
Ventilator-dependant Days
Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)
Secondary Outcome Measures
Muscle Strength Improvement
muscle power measurement by hand grip digital dynamometer every 2 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01895647
Brief Title
Effect of Different Electric Muscle Stimulation in Patients With Severe Sepsis and Respiratory Failure
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 Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment and high drop-out rate
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. 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:
Primary outcome: Ventilator-dependent days
Secondary outcome: change of hand drip muscle power/interleukin-1b/interleukin-6/interleukin-8/TNF-alpha
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Acute Respiratory Failure, Muscle Hypotonia, Inflammation, Weakness
Keywords
electric muscle stimulation, respiratory failure, sepsis, interleukin 6, interleukin 15
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biceps stimulation
Arm Type
Experimental
Arm Description
EMS
Arm Title
Quadriceps stimulation
Arm Type
Experimental
Arm Description
EMS
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group without electric muscle stimulation
Intervention Type
Device
Intervention Name(s)
EMS
Other Intervention Name(s)
HELEX 573
Intervention Description
Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
Primary Outcome Measure Information:
Title
Ventilator-dependant Days
Description
Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Muscle Strength Improvement
Description
muscle power measurement by hand grip digital dynamometer every 2 days
Time Frame
21 days
Other Pre-specified Outcome Measures:
Title
Inflammatory Cytokine Change
Description
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.
Time Frame
First 1 week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuang H Cheng, Msc
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
12. IPD Sharing Statement
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Effect of Different Electric Muscle Stimulation in Patients With Severe Sepsis and Respiratory Failure
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