Back to resultsElectrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock
Primary Purpose
Polyneuropathies, Septic Shock, Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electrical muscle stimulation
conventional physical therapy
Sponsored by
About this trial
This is an interventional prevention trial for Polyneuropathies focused on measuring polyneuropathies, muscle weakness, sepsis, septic shock, electrical stimulation, intensive care unit
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
- BMI> 35
- Epilepsy
- Those who have refused to sign informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
electrical muscle stimulation
conventional physical therapy
Arm Description
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus 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 according to the adaptation of the "Start to move" protocol of Gosselink et al
Outcomes
Primary Outcome Measures
intensive care unit acquired weakness
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 Outcome Measures
muscle strength
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).
muscle mass
ultrasonography
maximum inspiratory pressure
maximum inspiratory pressure
days of mechanical ventilation
number of days wirh mechanical ventilation
Number of Participants with weaning failure
Number of Participants who presented reintubation
days of ICU stay
number of days in ICU
mortality at 28 days
mortality
gait ability at hospital discharge
presence or not of gait ability
Full Information
NCT ID
NCT03765489
First Posted
November 12, 2018
Last Updated
December 3, 2018
Sponsor
University of Chile
1. Study Identification
Unique Protocol Identification Number
NCT03765489
Brief Title
Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 18, 2016 (Actual)
Primary Completion Date
June 21, 2018 (Actual)
Study Completion Date
June 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyneuropathies, Septic Shock, Muscle Weakness
Keywords
polyneuropathies, muscle weakness, sepsis, septic shock, electrical stimulation, intensive care unit
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
electrical muscle stimulation
Arm Type
Experimental
Arm Description
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus 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
Arm Title
conventional physical therapy
Arm Type
Active Comparator
Arm Description
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al
Intervention Type
Device
Intervention Name(s)
electrical muscle stimulation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
conventional physical therapy
Intervention Description
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al
Primary Outcome Measure Information:
Title
intensive care unit acquired weakness
Description
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
Time Frame
at awakening of the subject, an average of 8 days
Secondary Outcome Measure Information:
Title
muscle strength
Description
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).
Time Frame
at awakening of the subject, an average of 8 days
Title
muscle mass
Description
ultrasonography
Time Frame
at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days
Title
maximum inspiratory pressure
Description
maximum inspiratory pressure
Time Frame
at awakening of the subject, an average of 8 days
Title
days of mechanical ventilation
Description
number of days wirh mechanical ventilation
Time Frame
an average of 11 days
Title
Number of Participants with weaning failure
Description
Number of Participants who presented reintubation
Time Frame
48 hours post extubation day
Title
days of ICU stay
Description
number of days in ICU
Time Frame
at ICU discharge, an average of 18 days
Title
mortality at 28 days
Description
mortality
Time Frame
at 28 days post ICU admission
Title
gait ability at hospital discharge
Description
presence or not of gait ability
Time Frame
at hospital discharge, an averange of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
BMI> 35
Epilepsy
Those who have refused to sign informed consent
12. IPD Sharing Statement
Learn more about this trial
Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock
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