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Clinical Trials/NCT03765489
NCT03765489
Completed
Not Applicable

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

University of Chile0 sites23 target enrollmentNovember 18, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polyneuropathies
Sponsor
University of Chile
Enrollment
23
Primary Endpoint
intensive care unit acquired weakness
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 18, 2016
End Date
June 21, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Chile
Responsible Party
Principal Investigator
Principal Investigator

daniel arellano sepulveda

principal investigator

University of Chile

Eligibility Criteria

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
  • Those who have refused to sign informed consent

Outcomes

Primary Outcomes

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

  • muscle mass(at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days)
  • days of ICU stay(at ICU discharge, an average of 18 days)
  • mortality at 28 days(at 28 days post ICU admission)
  • muscle strength(at awakening of the subject, an average of 8 days)
  • maximum inspiratory pressure(at awakening of the subject, an average of 8 days)
  • days of mechanical ventilation(an average of 11 days)
  • Number of Participants with weaning failure(48 hours post extubation day)
  • gait ability at hospital discharge(at hospital discharge, an averange of 3 months)

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