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

Not Applicable

Terminated

• Conditions: Severe Sepsis; Acute Respiratory Failure; Inflammation; Weakness; Muscle Hypotonia
• Interventions: Device: EMS

• Registration Number: NCT01895647
• Lead Sponsor: Mackay Memorial Hospital

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)

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-29
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-10
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2017-09-01
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Results First Posted: 2019-07-08
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biceps stimulation	EMS	EMS
Quadriceps stimulation	EMS	EMS

Primary Outcome Measures

Name	Time	Method
Ventilator-dependant Days	21 days	Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)

Secondary Outcome Measures

Name	Time	Method
Muscle Strength Improvement	21 days	muscle power measurement by hand grip digital dynamometer every 2 days

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan