NCT01895647

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. 1.Primary outcome: Ventilator-dependent days
  2. 2.Secondary outcome: change of hand drip muscle power/interleukin-1b/interleukin-6/interleukin-8/TNF-alpha

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

July 8, 2019

Completed
Last Updated

July 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

June 29, 2013

Results QC Date

September 1, 2017

Last Update Submit

April 17, 2019

Conditions

Severe SepsisAcute Respiratory FailureMuscle HypotoniaInflammationWeakness

Keywords

electric muscle stimulationrespiratory failuresepsisinterleukin 6interleukin 15

Outcome Measures

Primary Outcomes (1)

  • Ventilator-dependant Days

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

    21 days

Secondary Outcomes (1)

  • Muscle Strength Improvement

    21 days

Other Outcomes (1)

  • Inflammatory Cytokine Change

    First 1 week.

Study Arms (3)

Biceps stimulation

EXPERIMENTAL

EMS

Device: EMS

Quadriceps stimulation

EXPERIMENTAL

EMS

Device: EMS

Control

NO INTERVENTION

Control group without electric muscle stimulation

Interventions

EMSDEVICE

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

Also known as: HELEX 573
Biceps stimulationQuadriceps stimulation

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe sepsis or septic shock patients with acute respiratory failure more than 3 days
  • adult patients( age\>20 years-old)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

MeSH Terms

Conditions

SepsisMuscle HypotoniaInflammationAstheniaRespiratory Insufficiency

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromePathologic ProcessesPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsRespiration DisordersRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Kuang-Hua Cheng
Organization
Mackay Memorial Hospital
jeff01@mmh.org.tw
886-975837711

Study Officials

  • Kuang H Cheng, Msc

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
visiting staff of pulmonary medicine

Study Record Dates

First Submitted

June 29, 2013

First Posted

July 10, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 8, 2019

Results First Posted

July 8, 2019

Record last verified: 2019-04

Locations

TW(1)