Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

Effect of Transcutaneous Electric Muscle Stimulation on Muscle Volume in Patients With Septic Shock

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Device: Transcutaneous electrical muscle stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Dept. of Intensive Care, Rigshospitalet, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: February 18, 2010
• First Submitted That Met QC Criteria: February 18, 2010
• First Posted (Estimate): February 19, 2010

Study Record Updates

• Last Update Posted (Estimate): February 19, 2010
• Last Update Submitted That Met QC Criteria: February 18, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: rehabilitation; Intensive care unit; recovery of function; muscular atrophy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: H-KF-283379