An interventional study of EMS in Severe Sepsis, Acute Respiratory Failure and Muscle Hypotonia, sponsored by Mackay Memorial Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-07-08.
Sponsored by Mackay Memorial Hospital · Not applicable, Interventional, and Prevention
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)
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 25 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EMS
Device: EMS
EMS
Device: EMS
Control group without electric muscle stimulation
Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
Also known as: HELEX 573
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
Muscle Strength Improvement
muscle power measurement by hand grip digital dynamometer every 2 days
Time frame: 21 days
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.
| Milestone | Biceps Stimulation | Quadriceps Stimulation | Control |
|---|---|---|---|
| Started | 8 | 10 | 7 |
| Completed | 8 | 10 | 7 |
| Not completed | 0 | 0 | 0 |
Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)
| days | Biceps Stimulation | Quadriceps Stimulation | Control |
|---|---|---|---|
| Ventilator-dependant Days | 6 (5.5 to 7) | 7 (5 to 11) | 6 (6 to 15) |
muscle power measurement by hand grip digital dynamometer every 2 days
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over The first 2 weeks after EMS applied in the ICU.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Biceps Stimulation | 2/8 (25%) | 0/8 (0%) | 0/8 (0%) |
| Quadriceps Stimulation | 3/10 (30%) | 0/10 (0%) | 0/10 (0%) |
| Control | 2/7 (28.6%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | Biceps Stimulation | Quadriceps Stimulation | Control | Total |
|---|---|---|---|---|
| Median | 78 (73 to 83) | 78 (73 to 83) | 77.5 (72 to 81) | 78 (72 to 82) |
| Sex: Female, Male(Participants) | Biceps Stimulation | Quadriceps Stimulation | Control | Total |
|---|---|---|---|---|
| Female | 5 | 8 | 5 | 18 |
| Male | 3 | 2 | 2 | 7 |
| Race and Ethnicity Not Collected(Participants) | Biceps Stimulation | Quadriceps Stimulation | Control | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Biceps Stimulation | Quadriceps Stimulation | Control | Total |
|---|---|---|---|---|
| Taiwan | 8 | 10 | 7 | 25 |
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Mackay Memorial Hospital