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Clinical Trials/NCT01895647
NCT01895647
Terminated
Not Applicable

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

Mackay Memorial Hospital1 site in 1 country25 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Sepsis
Sponsor
Mackay Memorial Hospital
Enrollment
25
Locations
1
Primary Endpoint
Ventilator-dependant Days
Status
Terminated
Last Updated
6 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
September 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kuang-Hua Cheng, MD

visiting staff of pulmonary medicine

Mackay Memorial Hospital

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

Outcomes

Primary Outcomes

Ventilator-dependant Days

Time Frame: 21 days

Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)

Secondary Outcomes

  • Muscle Strength Improvement(21 days)

Study Sites (1)

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