Severe Sepsis, Acute Respiratory Failure, Muscle Hypotonia, Inflammation, Weakness
Conditions
Keywords
electric muscle stimulation, respiratory failure, sepsis, interleukin 6, interleukin 15
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
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)
Interventions
DEVICEEMS
Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-dependant Days | 21 days | Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength Improvement | 21 days | muscle power measurement by hand grip digital dynamometer every 2 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Cytokine Change | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biceps Stimulation EMS
EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes | 8 |
| Quadriceps Stimulation EMS
EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes | 10 |
| Control Control group without electric muscle stimulation | 7 |
| Total | 25 |
Baseline characteristics
| Characteristic | Quadriceps Stimulation | Control | Total | Biceps Stimulation |
|---|---|---|---|---|
| Age, Continuous | 78 years | 77.5 years | 78 years | 78 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment Taiwan | 10 participants | 7 participants | 25 participants | 8 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 18 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 8 | 3 / 10 | 2 / 7 |
| other Total, other adverse events | 0 / 8 | 0 / 10 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 10 | 0 / 7 |
Outcome results
Primary
Ventilator-dependant Days
Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)
Time frame: 21 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Biceps Stimulation | Ventilator-dependant Days | 6 days |
| Quadriceps Stimulation | Ventilator-dependant Days | 7 days |
| Control | Ventilator-dependant Days | 6 days |
Secondary
Muscle Strength Improvement
muscle power measurement by hand grip digital dynamometer every 2 days
Time frame: 21 days
Population: The measurement cannot be collected because of the patients' drowsiness or incorporation.
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.
Time frame: First 1 week.
Population: The data was not completed because undetected IL-15 in first two samples. No data collection was performed for further samples.