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Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01071343
First Posted: February 19, 2010
Last Update Posted: February 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Copenhagen
Information provided by:
Rigshospitalet, Denmark
  Purpose

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.


Condition Intervention
Septic Shock Device: Transcutaneous electrical muscle stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Transcutaneous Electric Muscle Stimulation on Muscle Volume in Patients With Septic Shock

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans

Enrollment: 8
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcutaneous electrical muscle stimulation
    After randomization of the quadriceps muscles TEMS is applied on the intervention side for 7 consecutive days, 60 minutes per day.
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.

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071343


Locations
Denmark
Dept. of Intensive Care, Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Copenhagen
Investigators
Principal Investigator: Jesper B Poulsen, MD Rigshospitalet, University of Copenhagen
Study Chair: Kirsten Møller, MD, PhD, DMSci Rigshospitalet, University of Copenhagen
Study Chair: Anders Perner, MD, PhD Rigshospitalet, University of Copenhagen
Study Chair: Henrik Kehlet, MD, DMSci Rigshospitalet, University of Copenhagen
  More Information

Responsible Party: Jesper Brøndum Poulsen, MD, Rigshospitalet, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01071343     History of Changes
Other Study ID Numbers: H-KF-283379
First Submitted: February 18, 2010
First Posted: February 19, 2010
Last Update Posted: February 19, 2010
Last Verified: January 2010

Keywords provided by Rigshospitalet, Denmark:
muscular atrophy
recovery of function
rehabilitation
Intensive care unit

Additional relevant MeSH terms:
Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock