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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock; SIRS
• Intervention / Treatment: Procedure: Experimental Electrical Stimulation; Other: Conventional Physiotherapy; Procedure: Sham Electrical Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01308050
    • Hospital Sirio-Libanes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Electrical Stimulation; Experimental Electrical Stimulation for 40 minutos + conventional physiotherapy, during seven days.	Procedure: Experimental Electrical Stimulation; Experimental Electrical Stimulation (100Hz) during 40 minutes; Other: Conventional Physiotherapy; Active and passive exercises, and walking.
Sham Comparator: Sham Electrical Stimulation; Sham Electrical Stimulation for 40 minutes + conventional physiotherapy, during seven days.	Other: Conventional Physiotherapy; Active and passive exercises, and walking.; Procedure: Sham Electrical Stimulation; Sham Electrical Stimulation (5Hz) during 40 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass	Cross-sectional area	8 days
Muscle mass	Thickness	8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral muscle strength	Medical Research Council Scale will be used to measure the peripheral muscle strength. The patient's effort is graded on a scale of 0-5: Grade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance. Grade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side. Grade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane. Grade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle. Grade 0: No movement is observed. The total score ranges from 0 (complete tetraparesis) to 60 points (normal muscle strength).	8 days
Functional status	Functional status will be assessed using the Surgical Intensive Care Unit Optimal Mobilization Score. This score classifies mobility from 0 to 4: The SOMS "0 - No mobility" indicates that no mobilization should be considered due to the patients' clinical status. SOMS "1 - Passive mobilization" indicates that passive mobilization can be carried out in bed. SOMS "2 - Sitting" demonstrates that the patient is already able to sit on the bed or in a chair. SOMS "3 - Standing", indicates that the patient can perform orthostatism, with or without assistance. The highest level of SOMS "4 - Ambulation", shows that the patient is capable of ambulation.	8 days
Inflammatory	IL-1α	5 days
Inflammatory	IL-6	5 days
Inflammatory	IL-8	5 days
Inflammatory	IL-10	5 days
Inflammatory	IL-15	5 days
Inflammatory	MIP-1α	5 days
Inflammatory	TNF-α	5 days
Inflammatory	CRP	5 days
Metabolic, damage and muscular trophism markers	Lactate	5 days
Metabolic, damage and muscular trophism markers	CPK	5 days
Metabolic, damage and muscular trophism markers	IGF-1	5 days

Collaborators and Investigators

• Sponsor: Hospital Sirio-Libanes

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): October 21, 2024
• Study Completion (Actual): October 21, 2024

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: septic shock; electrical stimulation; sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock; Toxemia; Shock, Septic
• Other Study ID Numbers: 3.999.139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No