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Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01071343
First received: February 18, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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:

MedlinePlus related topics: Shock
U.S. FDA Resources

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 [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jesper Brøndum Poulsen, MD, Rigshospitalet, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01071343     History of Changes
Other Study ID Numbers: H-KF-283379
Study First Received: February 18, 2010
Last Updated: February 18, 2010
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on May 19, 2013