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Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

Primary Purpose

Septic Shock

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transcutaneous electrical muscle stimulation
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Septic Shock focused on measuring muscular atrophy, recovery of function, rehabilitation, Intensive care unit

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with septic shock admitted to the ICU of Rigshospitalet
  • written informed consent from patient or proxy

Exclusion Criteria:

  • diabetes
  • a focus of infection in or trauma to the lower extremities
  • a predicted ICU stay of less than seven days
  • severe respiratory or circulatory instability that precluded transportation of the patient to the CT scanner
  • patients receiving hihg dose corticosteroids (equivalent to methylprednisolone 1mg/kg/day or more)
  • pregnancy
  • severe psychiatric disorder
  • > 72 hours since the diagnosis of septic shock was established
  • > 7 days immobilisation prior to time of inclusion
  • patient receiving neuromuscular blocking agents
  • pre-existing neuromuscular disease
  • acute compression/affection of central or peripheral nerves relevant to the lower extremities
  • BMI > 30

Sites / Locations

  • Dept. of Intensive Care, Rigshospitalet, University of Copenhagen

Outcomes

Primary Outcome Measures

Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans

Secondary Outcome Measures

Full Information

First Posted
February 18, 2010
Last Updated
February 18, 2010
Sponsor
Rigshospitalet, Denmark
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01071343
Brief Title
Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients
Official Title
Effect of Transcutaneous Electric Muscle Stimulation on Muscle Volume in Patients With Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A growing number of critically ill patients survive intensive care to be discharged from hospital. However, critical illness and prolonged bedrest are associated with muscle wasting with subsequent implications for recovery of normal physical function. Thus, one year after discharge, survivors of septic shock have reported prolonged and severe impairment of physical function. Early interventions employed in the ICU to counteract loss of muscle mass may potentially improve physical outcome and reduce the overall burden of critical illness. As a potential supplement to physical therapy, transcutaneous electric muscle stimulation (TEMS) is a non-invasive method directed at maintaining skeletal muscle function through artificially induced contractions that are independent of patient efforts. TEMS has previously proven effective at preventing loss of muscle mass and force in a number of non-ICU patient groups, but has only been assessed sparsely in an ICU population where both immobilisation and systemic inflammation are present. Therefore, the aim of the present study was to assess the effect of early TEMS on muscle volume in patients admitted to the intensive care unit with septic shock. The investigators hypothesized that this intervention would preserve muscle volume during septic shock.
Detailed Description
To ensures baseline comparability, eliminates many of the inter-individual confounding factors often present in ICU patients and enhances statistical strength we designed a study where we included a well-defined group of patients with septic shock in a single-legged exercise design, using the contralateral leg as the (paired) control and used a two-channel stimulation approach with 3-D evaluation of muscle volume changes based on CT scans. After randomization of the quadriceps muscles TEMS is applied on the intervention side for 7 consecutive days, 60 minutes per day. All patients undergoes CT scans of both thighs before and immediately after the 7-day treatment period. The quadriceps muscle is then manually delineated on the transverse CT slices, and muscle volumes are calculated after 3-D reconstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
muscular atrophy, recovery of function, rehabilitation, Intensive care unit

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical muscle stimulation
Intervention Description
After randomization of the quadriceps muscles TEMS is applied on the intervention side for 7 consecutive days, 60 minutes per day.
Primary Outcome Measure Information:
Title
Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with septic shock admitted to the ICU of Rigshospitalet written informed consent from patient or proxy Exclusion Criteria: diabetes a focus of infection in or trauma to the lower extremities a predicted ICU stay of less than seven days severe respiratory or circulatory instability that precluded transportation of the patient to the CT scanner patients receiving hihg dose corticosteroids (equivalent to methylprednisolone 1mg/kg/day or more) pregnancy severe psychiatric disorder > 72 hours since the diagnosis of septic shock was established > 7 days immobilisation prior to time of inclusion patient receiving neuromuscular blocking agents pre-existing neuromuscular disease acute compression/affection of central or peripheral nerves relevant to the lower extremities BMI > 30
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper B Poulsen, MD
Organizational Affiliation
Rigshospitalet, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirsten Møller, MD, PhD, DMSci
Organizational Affiliation
Rigshospitalet, University of Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anders Perner, MD, PhD
Organizational Affiliation
Rigshospitalet, University of Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Henrik Kehlet, MD, DMSci
Organizational Affiliation
Rigshospitalet, University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Intensive Care, Rigshospitalet, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

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