Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071343
• Other study ID #: H-KF-283379
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: February 18, 2010
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: January 2010
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

Device:
• Transcutaneous electrical muscle stimulation
After randomization of the quadriceps muscles TEMS is applied on the intervention side for 7 consecutive days, 60 minutes per day.

Locations

Country	Name	City	State
Denmark	Dept. of Intensive Care, Rigshospitalet, University of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans			No