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Completed

NCT Number: NCT03754257

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

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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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms SIRS Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sírio-Libanês

São Paulo, 01308050, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental Electrical Stimulation

Procedure

Experimental Electrical Stimulation (100Hz) during 40 minutes

Sham Electrical Stimulation

Procedure

Sham Electrical Stimulation (5Hz) during 40 minutes

Conventional Physiotherapy

Other

Active and passive exercises, and walking.

Primary outcomes

  1. Muscle mass

    Time frame: 8 days

    Cross-sectional area

  2. Muscle mass

    Time frame: 8 days

    Thickness

Secondary outcomes

  1. Peripheral muscle strength

    Time frame: 8 days

    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).

  2. Functional status

    Time frame: 8 days

    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.

  3. Inflammatory

    Time frame: 5 days

    IL-1α

  4. Inflammatory

    Time frame: 5 days

    IL-6

  5. Inflammatory

    Time frame: 5 days

    IL-8

  6. Inflammatory

    Time frame: 5 days

    IL-10

  7. Inflammatory

    Time frame: 5 days

    IL-15

  8. Inflammatory

    Time frame: 5 days

    MIP-1α

  9. Inflammatory

    Time frame: 5 days

    TNF-α

  10. Inflammatory

    Time frame: 5 days

    CRP

  11. Metabolic, damage and muscular trophism markers

    Time frame: 5 days

    Lactate

  12. Metabolic, damage and muscular trophism markers

    Time frame: 5 days

    CPK

  13. Metabolic, damage and muscular trophism markers

    Time frame: 5 days

    IGF-1

Sponsors and collaborators

Lead sponsor

Hospital Sirio-Libanes

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2018
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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