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

NCT01895647 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-07-08

Study results available
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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

Conditions

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

Interventions

DEVICE

EMS

Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes

Sponsors & Collaborators

  • Mackay Memorial Hospital

    lead OTHER

Principal Investigators

  • Kuang H Cheng, Msc · Mackay Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01895647 on ClinicalTrials.gov