Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

• ClinicalTrials.gov Identifier: NCT01071343
• Recruitment Status: Completed
• First Posted: February 19, 2010
• Last Update Posted: February 19, 2010
• Sponsor: Rigshospitalet, Denmark
• Collaborator: University of Copenhagen
• Information provided by: Rigshospitalet, Denmark

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.

Condition or disease	Intervention/treatment	Phase
Septic Shock	Device: Transcutaneous electrical muscle stimulation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• 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
• Study Start Date: January 2008
• Actual Primary Completion Date: April 2009
• Actual Study Completion Date: April 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: H-KF-283379
• 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; Shock; Pathologic Processes; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation