Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With Sepsis

Study Overview
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Brief Summary
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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 sepsis or septic shock. Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of 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 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
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This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of 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.

Official Title
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Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With Sepsis and Septic Shock - Randomized, Controlled and Double-blind Clinical Trial

Conditions
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Sepsis, Septic Shock

Intervention / Treatment
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* Procedure: Experimental Electrical Stimulation
* Procedure: Sham Electrical Stimulation
* Other: Conventional Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients admitted to the ICU with a diagnosis of 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. Exclusion Criteria: heart attack, death.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Electrical Stimulation<br>Experimental Electrical Stimulation for 40 minutos + conventional physiotherapy, during seven days. | Procedure: Experimental Electrical Stimulation<br>* Experimental Electrical Stimulation (100Hz) during 40 minutes<br>Other: Conventional Physiotherapy<br>* Active and passive exercises, and walking.<br>|
| Sham Comparator: Sham Electrical Stimulation<br>Sham Electrical Stimulation for 40 minutes + conventional physiotherapy, during seven days. | Procedure: Sham Electrical Stimulation<br>* Sham Electrical Stimulation (5Hz) during 40 minutes<br>Other: Conventional Physiotherapy<br>* Active and passive exercises, and walking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass | Cross-sectional area | 8 days | 
| Muscle mass | Thickness | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 8 days | 
| Inflammatory | IL-6 | 8 days | 
| Inflammatory | IL-10 | 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. | 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, septic shock, electrical stimulation