Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

NCT ID: NCT01071343

Last Updated: 2010-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-04-30

Brief 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.

Detailed 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.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Rigshospitalet, University of Copenhagen

Principal Investigators

Jesper B Poulsen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, University of Copenhagen

Kirsten Møller, MD, PhD, DMSci

Role: STUDY_CHAIR

Rigshospitalet, University of Copenhagen

Anders Perner, MD, PhD

Role: STUDY_CHAIR

Rigshospitalet, University of Copenhagen

Henrik Kehlet, MD, DMSci

Role: STUDY_CHAIR

Rigshospitalet, University of Copenhagen

Locations

Dept. of Intensive Care, Rigshospitalet, University of Copenhagen

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-KF-283379

Identifier Type: -

Identifier Source: org_study_id