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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01895647
• Other study ID #: 13MMHIS060
• Status: Terminated
• Phase: N/A
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: April 2019
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Inflammation
• Muscle Hypotonia
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Sepsis
• Severe Sepsis
• Toxemia
• Weakness

Intervention

Device:
• EMS
Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inflammatory Cytokine Change	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.	First 1 week.
Primary	Ventilator-dependant Days	Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)	21 days
Secondary	Muscle Strength Improvement	muscle power measurement by hand grip digital dynamometer every 2 days	21 days