Severe SepsisNCT01895647
Effect of Different Electric Muscle Stimulation in Patients With Severe Sepsis and Respiratory Failure
A study testing EMS in people with Severe Sepsis and Acute Respiratory Failure, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 . Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Severe Sepsis, Acute Respiratory Failure, Muscle Hypotonia
- What is being tested?
- EMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe sepsis or septic shock patients with acute respiratory failure more than 3 days
- adult patients( age>20 years-old)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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:
- Primary outcome: Ventilator-dependent days
- Secondary outcome: change of hand drip muscle power/interleukin-1b/interleukin-6/interleukin-8/TNF-alpha
Read the 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)
- Being tested
- EMS
- Keywords
- electric muscle stimulation, respiratory failure, sepsis, interleukin 6, interleukin 15
- Medical subject headings
- Sepsis, Muscle Hypotonia, Inflammation, Asthenia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMSDevice
Also called HELEX 573
Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
| Study group | Role | What they receive |
|---|---|---|
| Biceps stimulation | Experimental | EMS Receives: Device: EMS |
| Quadriceps stimulation | Experimental | EMS Receives: Device: EMS |
| Control | No intervention | Control group without electric muscle stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-dependant Days
Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)
Measured: 21 days
Secondary outcomes (1)
Muscle Strength Improvement
muscle power measurement by hand grip digital dynamometer every 2 days
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: slow recruitment and high drop-out rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuang-Hua Cheng, MD, Mackay Memorial Hospital
- Investigators
- Kuang H Cheng, Msc, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895647
- Sponsor's protocol ID
- 13MMHIS060
- Status last verified
- Apr 2019
- First submitted
- 29 Jun 2013
- Last updated
- 8 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01895647
- Acronym / sponsor ID
- 13MMHIS060
- Keywords
- electric muscle stimulation, respiratory failure, sepsis, interleukin 6, interleukin 15
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment and high drop-out rate
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 8 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Primary outcome: Ventilator-dependent days
- 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biceps stimulation | Experimental | Device: EMSEMS |
| Quadriceps stimulation | Experimental | Device: EMSEMS |
| Control | No intervention | –Control group without electric muscle stimulation |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- severe sepsis or septic shock patients with acute respiratory failure more than 3 days
- adult patients( age>20 years-old)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMSAlso: HELEX 573Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes | Device | Biceps stimulation, Quadriceps stimulation |
Primary outcome
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)
1 secondary outcome
Muscle Strength Improvement
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuang H Cheng, Msc principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMS in people with Severe Sepsis and Acute Respiratory Failure, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-dependant Days (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.