Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With Sepsis

Sepsis Clinical Trial

Official title:

Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With Sepsis and Septic Shock - Randomized, Controlled and Double-blind Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03754257
• Other study ID #: HSL 2018-26
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Hospital Sirio-Libanes
• Contact: Wellington Yamaguti, PHD
• Phone: 1133940200
• Email: wellington.psyamaguti[@]hsl.org.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 sepsis or septic shock. Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of 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 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.

Description:

This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients admitted to the ICU with a diagnosis of 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.

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

Procedure:
• Experimental Electrical Stimulation
Experimental Electrical Stimulation (100Hz) during 40 minutes
• Sham Electrical Stimulation
Sham Electrical Stimulation (5Hz) during 40 minutes

Other:
• Conventional Physiotherapy
Active and passive exercises, and walking.

Locations

Country	Name	City	State
Brazil	Hospital Sírio-Libanês	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	Cross-sectional area	8 days
Primary	Muscle mass	Thickness	8 days
Secondary	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
Secondary	Inflammatory	IL-6	8 days
Secondary	Inflammatory	IL-10	8 days
Secondary	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