Effect of Different Electric Muscle Stimulation in Patients With Severe Sepsis and Respiratory Failure

Mackay Memorial Hospital

Status: Terminated

Conditions: Inflammation; Weakness; Muscle Hypotonia; Acute Respiratory Failure; Severe Sepsis

Treatments: Device: EMS

Study type: Interventional

Funder types: Other

Identifiers

NCT01895647

13MMHIS060

Details and patient eligibility

About

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

Full 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)

Enrollment: 25 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Biceps stimulation

Experimental group

Description:

EMS

Treatment:

Device: EMS

Quadriceps stimulation

Experimental group

Description:

EMS

Treatment:

Device: EMS

Control

No Intervention group

Description:

Control group without electric muscle stimulation