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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2024-10-21

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 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.

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Detailed Description

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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

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Sepsis Septic Shock SIRS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental Electrical Stimulation

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

Group Type EXPERIMENTAL

Experimental Electrical Stimulation

Intervention Type PROCEDURE

Experimental Electrical Stimulation (100Hz) during 40 minutes

Conventional Physiotherapy

Intervention Type OTHER

Active and passive exercises, and walking.

Sham Electrical Stimulation

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

Group Type SHAM_COMPARATOR

Sham Electrical Stimulation

Intervention Type PROCEDURE

Sham Electrical Stimulation (5Hz) during 40 minutes

Conventional Physiotherapy

Intervention Type OTHER

Active and passive exercises, and walking.

Interventions

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Experimental Electrical Stimulation

Experimental Electrical Stimulation (100Hz) during 40 minutes

Intervention Type PROCEDURE

Sham Electrical Stimulation

Sham Electrical Stimulation (5Hz) during 40 minutes

Intervention Type PROCEDURE

Conventional Physiotherapy

Active and passive exercises, and walking.

Intervention Type OTHER

Eligibility Criteria

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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.