Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients
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 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|
- Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Device: Transcutaneous electrical muscle stimulation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071343
|Dept. of Intensive Care, Rigshospitalet, University of Copenhagen|
|Copenhagen, Denmark, 2100|
|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|