SepsisNCT03754257
Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock
A study testing Experimental Electrical Stimulation and Conventional Physiotherapy in people with Sepsis and Septic Shock, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
Background: Electrical stimulation has been used in critical patients as an adjunct strategy of early rehabilitation. In septic or septic shock patients there are reports of only two studies in the literature, with conflicting results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, SIRS
- What is being tested?
- Experimental Electrical Stimulation and Conventional Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients admitted to the ICU with a diagnosis of SIRS, sepsis or septic shock,
- aged ≥ 18 years,
- body mass index (BMI) ≤ 35 kg / m2,
- without diabetic polyneuropathy,
- without cardiac pacemaker,
- without diagnosis of neuromuscular diseases,
- absence of skin lesions.
Who cannot join
- heart attack,
- death.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock - Randomized, Controlled and Double-blind Clinical Trial
Background: Electrical stimulation has been used in critical patients as an adjunct strategy of early rehabilitation. In septic or septic shock patients there are reports of only two studies in the literature, with conflicting results.
Objective: To evaluate the effects of electrical stimulation in the prevention of muscle mass loss in patients admitted to the ICU with systemic inflammatory response syndrome (SIRS), sepsis or septic shock.
Read more
Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
Expected results: Electrical stimulation is expected to be able to prevent loss of muscle mass in patients admitted to the ICU with SIRS, sepsis or septic shock. In addition, it is expected to be able to preserve strength in this population without increasing the pro-inflammatory or metabolic response.
Read the detailed description
This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group.They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
- Conditions
- Sepsis, Septic Shock, SIRS
- Being tested
- Experimental Electrical Stimulation, Sham Electrical Stimulation, Conventional Physiotherapy
- Keywords
- sepsis, septic shock, electrical stimulation
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Electrical StimulationProcedure or surgery
Experimental Electrical Stimulation (100Hz) during 40 minutes
Sham Electrical StimulationProcedure or surgery
Sham Electrical Stimulation (5Hz) during 40 minutes
Conventional PhysiotherapyOther
Active and passive exercises, and walking.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Electrical Stimulation | Experimental | Experimental Electrical Stimulation for 40 minutos + conventional physiotherapy, during seven days. Receives: Procedure: Experimental Electrical Stimulation; Other: Conventional Physiotherapy |
| Sham Electrical Stimulation | Sham comparator | Sham Electrical Stimulation for 40 minutes + conventional physiotherapy, during seven days. Receives: Procedure: Sham Electrical Stimulation; Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Cross-sectional area
Measured: 8 days
Muscle mass
Thickness
Measured: 8 days
Secondary outcomes (13)
Peripheral muscle strength
Medical Research Council Scale will be used to measure the peripheral muscle strength. The patient's effort is graded on a scale of 0-5:
Grade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance.
Grade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side.
Grade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane.
Grade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle.
Grade 0: No movement is observed. The total score ranges from 0 (complete tetraparesis) to 60 points (normal muscle strength).
Measured: 8 days
Functional status
Functional status will be assessed using the Surgical Intensive Care Unit Optimal Mobilization Score. This score classifies mobility from 0 to 4:
The SOMS "0 - No mobility" indicates that no mobilization should be considered due to the patients' clinical status.
SOMS "1 - Passive mobilization" indicates that passive mobilization can be carried out in bed.
SOMS "2 - Sitting" demonstrates that the patient is already able to sit on the bed or in a chair.
SOMS "3 - Standing", indicates that the patient can perform orthostatism, with or without assistance.
The highest level of SOMS "4 - Ambulation", shows that the patient is capable of ambulation.
Measured: 8 days
Inflammatory
IL-1α
Measured: 5 days
Inflammatory
IL-6
Measured: 5 days
Inflammatory
IL-8
Measured: 5 days
Inflammatory
IL-10
Measured: 5 days
Inflammatory
IL-15
Measured: 5 days
Inflammatory
MIP-1α
Measured: 5 days
Inflammatory
TNF-α
Measured: 5 days
Inflammatory
CRP
Measured: 5 days
Metabolic, damage and muscular trophism markers
Lactate
Measured: 5 days
Metabolic, damage and muscular trophism markers
CPK
Measured: 5 days
Metabolic, damage and muscular trophism markers
IGF-1
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Oct 2018
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wellington Yamaguti, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754257
- Sponsor's protocol ID
- 3.999.139
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2018
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock - Randomized, Controlled and Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03754257
- Acronym / sponsor ID
- 3.999.139
- Conditions
- Sepsis, Septic Shock, SIRS
- Keywords
- sepsis, septic shock, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Electrical stimulation has been used in critical patients as an adjunct strategy of early rehabilitation. In septic or septic shock patients there are reports of only two studies in the literature, with conflicting results.
Objective: To evaluate the effects of electrical stimulation in the prevention of muscle mass loss in patients admitted to the ICU with systemic inflammatory response syndrome (SIRS), sepsis or septic shock.
Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
Expected results: Electrical stimulation is expected to be able to prevent loss of muscle mass in patients admitted to the ICU with SIRS, sepsis or septic shock. In addition, it is expected to be able to preserve strength in this population without increasing the pro-inflammatory or metabolic response.
Detailed description
This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group.They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Electrical Stimulation | Experimental | Procedure: Experimental Electrical Stimulation, Other: Conventional PhysiotherapyExperimental Electrical Stimulation for 40 minutos + conventional physiotherapy, during seven days. |
| Sham Electrical Stimulation | Sham comparator | Procedure: Sham Electrical Stimulation, Other: Conventional PhysiotherapySham Electrical Stimulation for 40 minutes + conventional physiotherapy, during seven days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients admitted to the ICU with a diagnosis of SIRS, sepsis or septic shock,
- aged ≥ 18 years,
- body mass index (BMI) ≤ 35 kg / m2,
- without diabetic polyneuropathy,
- without cardiac pacemaker,
Key exclusion criteria (2 listed)
- heart attack,
- death.
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 |
|---|---|---|
| Experimental Electrical StimulationExperimental Electrical Stimulation (100Hz) during 40 minutes | Procedure or surgery | Experimental Electrical Stimulation |
| Sham Electrical StimulationSham Electrical Stimulation (5Hz) during 40 minutes | Procedure or surgery | Sham Electrical Stimulation |
| Conventional PhysiotherapyActive and passive exercises, and walking. | Other | Experimental Electrical Stimulation, Sham Electrical Stimulation |
Primary outcome
Muscle mass
Time frame: 8 days
Cross-sectional area
Muscle mass
Time frame: 8 days
Thickness
13 secondary outcomes
Peripheral muscle strength
Time frame: 8 days
Functional status
Time frame: 8 days
Inflammatory
Time frame: 5 days
Inflammatory
Time frame: 5 days
Inflammatory
Time frame: 5 days
Inflammatory
Time frame: 5 days
Inflammatory
Time frame: 5 days
Inflammatory
Time frame: 5 days
Inflammatory
Time frame: 5 days
Inflammatory
Time frame: 5 days
Metabolic, damage and muscular trophism markers
Time frame: 5 days
Metabolic, damage and muscular trophism markers
Time frame: 5 days
Metabolic, damage and muscular trophism markers
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Electrical Stimulation and Conventional Physiotherapy in people with Sepsis and Septic Shock, run by Hospital Sirio-Libanes at 1 site in Brazil.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 29 Oct 2024. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle mass (time frame: 8 days). The study lists 2 primary outcomes in all. 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 29 Oct 2024.