Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock

Hospital Sirio-Libanes

Status: Completed

Conditions: SIRS; Septic Shock; Sepsis

Treatments: Procedure: Sham Electrical Stimulation; Other: Conventional Physiotherapy; Procedure: Experimental Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03754257

3.999.139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Experimental Electrical Stimulation

Experimental group

Description:

Experimental Electrical Stimulation for 40 minutos + conventional physiotherapy, during seven days.

Treatment:

Procedure: Experimental Electrical Stimulation

Other: Conventional Physiotherapy

Sham Electrical Stimulation

Sham Comparator group

Description:

Sham Electrical Stimulation for 40 minutes + conventional physiotherapy, during seven days.

Treatment:

Other: Conventional Physiotherapy

Procedure: Sham Electrical Stimulation