Clinical trial NCT03754257: Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Septic Shock
SIRS
Keywords: sepsis
septic shock
electrical stimulation
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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,
* death.

Primary outcomes:
measure: Muscle mass
timeFrame: 8 days
measure: Muscle mass
timeFrame: 8 days
Secondary outcomes:
measure: Peripheral muscle strength
timeFrame: 8 days
measure: Functional status
timeFrame: 8 days
measure: Inflammatory
timeFrame: 5 days
measure: Inflammatory
timeFrame: 5 days
measure: Inflammatory
timeFrame: 5 days
measure: Inflammatory
timeFrame: 5 days
measure: Inflammatory
timeFrame: 5 days
measure: Inflammatory
timeFrame: 5 days
measure: Inflammatory
timeFrame: 5 days
measure: Inflammatory
timeFrame: 5 days
measure: Metabolic, damage and muscular trophism markers
timeFrame: 5 days
measure: Metabolic, damage and muscular trophism markers
timeFrame: 5 days
measure: Metabolic, damage and muscular trophism markers
timeFrame: 5 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sírio-Libanês
Study officials:
References: