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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Hospital Sirio-Libanes
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Muscle mass
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
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.
Investigators
Wellington Yamaguti
Wellington Pereira dos Santos Yamaguti
Hospital Sirio-Libanes
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •heart attack,
Outcomes
Primary Outcomes
Muscle mass
Time Frame: 8 days
Thickness
Secondary Outcomes
- Peripheral muscle strength(8 days)
- Functional status(8 days)
- Inflammatory(5 days)
- Metabolic, damage and muscular trophism markers(5 days)