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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Mackay Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Kuang-Hua Cheng, Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01895647
First received: June 29, 2013
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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

Condition Intervention
Severe Sepsis
Acute Respiratory Failure
Muscle Hypotonia
Inflammation
Weakness
Device: EMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • ventilator-dependant days [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)


Secondary Outcome Measures:
  • Muscle strength improvement [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    muscle power measurement by hand grip digital dynamometer every 2 days


Other Outcome Measures:
  • Inflammatory cytokine change [ Time Frame: First 1 week. ] [ Designated as safety issue: No ]
    Serum interleukin(IL)-1B, IL-6, IL-8, IL-10, IL-15 and tumor necrosis factor(TNF)-alpha will be measured before/after first section of EMS, and after fifth EMS section.


Estimated Enrollment: 150
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biceps stimulation
EMS
Device: EMS
Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
Other Name: HELEX 573
Experimental: Quadriceps stimulation
EMS
Device: EMS
Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
Other Name: HELEX 573
No Intervention: Control
Control group without electric muscle stimulation

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

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895647

Contacts
Contact: Kuang H Cheng, MD +886-9-75837711 jeff01@ms1.mmh.org.tw

Locations
Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 10449
Contact: Kuang H Cheng, MD       jeff01@ms1.mmh.org.tw   
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Kuang H Cheng, MD Mackay Memorial Hospital
  More Information

No publications provided

Responsible Party: Kuang-Hua Cheng, visiting staff of pulmonary medicine, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01895647     History of Changes
Other Study ID Numbers: 13MMHIS060
Study First Received: June 29, 2013
Last Updated: July 5, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Mackay Memorial Hospital:
electric muscle stimulation
respiratory failure
sepsis
interleukin 6
interleukin 15

Additional relevant MeSH terms:
Muscle Hypotonia
Inflammation
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Sepsis
Toxemia
Infection
Lung Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 20, 2014