Septic Shock Clinical Trial
Official title:
Effect of Transcutaneous Electric Muscle Stimulation on Muscle Volume in Patients With Septic Shock
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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