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Completed

NCT Number: NCT01071343

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.

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Key information

Conditions

Septic Shock Atrophy Infections Inflammation Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Intensive Care, Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous electrical muscle stimulation

Device

After randomization of the quadriceps muscles TEMS is applied on the intervention side for 7 consecutive days, 60 minutes per day.

Primary outcomes

  1. Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Effect of Transcutaneous Electric Muscle Stimulation on Muscle Volume in Patients With Septic Shock

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 19, 2010
Registry last updated
Feb 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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