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

December 3, 2018 updated by: daniel arellano sepulveda, University of Chile

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: electrical muscle stimulation
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
Device: electrical muscle stimulation
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
Procedure: conventional physical therapy
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al
ACTIVE_COMPARATOR: conventional physical therapy
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al
Procedure: conventional physical therapy
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at awakening of the subject, an average of 8 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
at awakening of the subject, an average of 8 days
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
at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days
maximum inspiratory pressure
Time Frame: 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
Time Frame: an average of 11 days
number of days wirh mechanical ventilation
an average of 11 days
Number of Participants with weaning failure
Time Frame: 48 hours post extubation day
Number of Participants who presented reintubation
48 hours post extubation day
days of ICU stay
Time Frame: at ICU discharge, an average of 18 days
number of days in ICU
at ICU discharge, an average of 18 days
mortality at 28 days
Time Frame: at 28 days post ICU admission
mortality
at 28 days post ICU admission
gait ability at hospital discharge
Time Frame: at hospital discharge, an averange of 3 months
presence or not of gait ability
at hospital discharge, an averange of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OAIC 847/16

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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