NCT01895647

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Severe Sepsis
• Acute Respiratory Failure
• Muscle Hypotonia
• Inflammation
• Weakness

Interventions

Type	Name	Description
DEVICE	EMS	Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-07-10
• Last updated: 2019-07-08
• Results posted: 2019-07-08

Locations

1 site across 1 country: Taiwan