Clinical trial NCT01895647: 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
Overall status: TERMINATED
Phase: NA
Conditions: Severe Sepsis
Acute Respiratory Failure
Muscle Hypotonia
Inflammation
Weakness
Keywords: electric muscle stimulation
respiratory failure
sepsis
interleukin 6
interleukin 15
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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

Primary outcomes:
measure: Ventilator-dependant Days
timeFrame: 21 days
Secondary outcomes:
measure: Muscle Strength Improvement
timeFrame: 21 days
Other outcomes:
measure: Inflammatory Cytokine Change
timeFrame: First 1 week.
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Kuang H Cheng, Msc
role: PRINCIPAL_INVESTIGATOR
References: