Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01071343|
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : February 19, 2010
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|
|Septic Shock||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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Transcutaneous Electric Muscle Stimulation on Muscle Volume in Patients With Septic Shock|
|Study Start Date :||January 2008|
|Primary Completion Date :||April 2009|
|Study Completion Date :||April 2009|
Device: Transcutaneous electrical muscle stimulation
- Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|