Clinical trial NCT01071343: Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients
Official title: Effect of Transcutaneous Electric Muscle Stimulation on Muscle Volume in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: muscular atrophy
recovery of function
rehabilitation
Intensive care unit
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2010-02-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Intensive Care, Rigshospitalet, University of Copenhagen
Study officials:
affiliation: Rigshospitalet, University of Copenhagen
name: Jesper B Poulsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, University of Copenhagen
name: Kirsten Møller, MD, PhD, DMSci
role: STUDY_CHAIR
affiliation: Rigshospitalet, University of Copenhagen
name: Anders Perner, MD, PhD
role: STUDY_CHAIR
affiliation: Rigshospitalet, University of Copenhagen
name: Henrik Kehlet, MD, DMSci
role: STUDY_CHAIR
References: