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

NCT03754257 | Completed

• 1 other identifier: 3.999.139
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock; SIRS

Keywords

sepsis; septic shock; electrical stimulation

Outcome Measures

Primary Outcomes (2)

• Muscle mass

  Cross-sectional area

  8 days

• Muscle mass

  Thickness

  8 days

Secondary Outcomes (13)

• Peripheral muscle strength

  8 days

• Functional status

  8 days

• Inflammatory

  5 days

• Inflammatory

  5 days

• Inflammatory

  5 days

Study Arms (2)

Experimental Electrical Stimulation

EXPERIMENTAL

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

Procedure: Experimental Electrical Stimulation; Other: Conventional Physiotherapy

Sham Electrical Stimulation

SHAM COMPARATOR

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

Procedure: Sham Electrical Stimulation; Other: Conventional Physiotherapy

Interventions

Experimental Electrical Stimulation PROCEDURE

Experimental Electrical Stimulation (100Hz) during 40 minutes

Experimental Electrical Stimulation

Sham Electrical Stimulation PROCEDURE

Sham Electrical Stimulation (5Hz) during 40 minutes

Sham Electrical Stimulation

Conventional Physiotherapy OTHER

Active and passive exercises, and walking.

Experimental Electrical Stimulation; Sham Electrical Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• heart attack,
• death.

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospital Sírio-Libanês

São Paulo, 01308050, Brazil

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wellington Pereira dos Santos Yamaguti

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 27, 2018
• Study Start: October 1, 2018
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)