Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

Not Applicable

Completed

• Conditions: Septic Shock

• Registration Number: NCT01071343
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2010-01
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-18
• Last Update Submitted: 2010-02-18
• Study First Posted: 2010-02-19
• Last Update Posted: 2010-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dept. of Intensive Care, Rigshospitalet, University of Copenhagen; 🇩🇰 Copenhagen, Denmark