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Completed

NCT Number: NCT03765489

Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock

The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.

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Key information

Conditions

Polyneuropathies Infections Inflammation Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sepsis Septic Shock Shock Shock, Septic Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects admitted to the ICU of the HCUCH in the period between November 2016 to August 2017 and January to June 2018
  • Diagnosis of severe sepsis or septic shock
  • More than 48 hours in VMI
  • With sedation and / or neuromuscular blockade
  • Autovalent prior to admission to the ICU

Exclusion criteria

  • Subjects from other hospitals / clinics or units of the hospital
  • Multiple trauma
  • Previous neuromuscular pathology
  • Pacemaker users
  • Pregnant women
  • BMI> 35
  • Epilepsy
  • Those who have refused to sign informed consent

Treatment and study plan

Electrical muscle stimulation

Device

electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction

Conventional Physical Therapy

Procedure

conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al

Primary outcomes

  1. intensive care unit acquired weakness

    Time frame: at awakening of the subject, an average of 8 days

    Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness

Secondary outcomes

  1. muscle strength

    Time frame: at awakening of the subject, an average of 8 days

    Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength).

  2. muscle mass

    Time frame: at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days

    ultrasonography

  3. maximum inspiratory pressure

    Time frame: at awakening of the subject, an average of 8 days

    maximum inspiratory pressure

  4. days of mechanical ventilation

    Time frame: an average of 11 days

    number of days wirh mechanical ventilation

  5. Number of Participants with weaning failure

    Time frame: 48 hours post extubation day

    Number of Participants who presented reintubation

  6. days of ICU stay

    Time frame: at ICU discharge, an average of 18 days

    number of days in ICU

  7. mortality at 28 days

    Time frame: at 28 days post ICU admission

    mortality

  8. gait ability at hospital discharge

    Time frame: at hospital discharge, an averange of 3 months

    presence or not of gait ability

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

Electrical Muscle Stimulation in the Development of Acquired Weakness in the Intensive Care Unit in Adult Patients With Severe Sepsis and Septic Shock at the Clinic Hospital of the Univerisity of Chile: Results of a Pilot Randomized Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2018
Registry last updated
Dec 5, 2018

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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