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slow recruitment and high drop-out rate
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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:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biceps stimulation | Experimental | EMS |
|
| Quadriceps stimulation | Experimental | EMS |
|
| Control | No Intervention | Control group without electric muscle stimulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMS | Device | Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Strength Improvement | muscle power measurement by hand grip digital dynamometer every 2 days | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Cytokine Change | 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. | First 1 week. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kuang H Cheng, Msc | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biceps Stimulation | EMS EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes |
| FG001 | Quadriceps Stimulation | EMS EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes |
| FG002 | Control | Control group without electric muscle stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biceps Stimulation | EMS EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes |
| BG001 | Quadriceps Stimulation | EMS EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ventilator-dependant Days | Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most) | Posted | Median | Inter-Quartile Range | days | 21 days |
|
The first 2 weeks after EMS applied in the ICU.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biceps Stimulation | EMS EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kuang-Hua Cheng | Mackay Memorial Hospital | 886-975837711 | jeff01@mmh.org.tw |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D009123 | Muscle Hypotonia |
| D007249 | Inflammation |
| D001247 | Asthenia |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BG002 | Control | Control group without electric muscle stimulation |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Control group without electric muscle stimulation
|
|
| Secondary | Muscle Strength Improvement | muscle power measurement by hand grip digital dynamometer every 2 days | The measurement cannot be collected because of the patients' drowsiness or incorporation. | Posted | 21 days |
|
|
| Other Pre-specified | Inflammatory Cytokine Change | 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. | The data was not completed because undetected IL-15 in first two samples. No data collection was performed for further samples. | Posted | First 1 week. |
|
|
| 2 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Quadriceps Stimulation | EMS EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes | 3 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Control | Control group without electric muscle stimulation | 2 | 7 | 0 | 7 | 0 | 7 |
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| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| Male |
|