Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

NCT01071343 | Completed

• 1 other identifier: H-KF-283379
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

muscular atrophy; recovery of function; rehabilitation; Intensive care unit

Outcome Measures

Primary Outcomes (1)

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with septic shock admitted to the ICU of Rigshospitalet
• written informed consent from patient or proxy

You may not qualify if:

• 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
• patient receiving neuromuscular blocking agents
• pre-existing neuromuscular disease
• acute compression/affection of central or peripheral nerves relevant to the lower extremities
• BMI \> 30

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator

Study Sites (1)

Dept. of Intensive Care, Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Shock, Septic; Muscular Atrophy

Condition Hierarchy (Ancestors)

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

Study Officials

• Jesper B Poulsen, MD

  Rigshospitalet, University of Copenhagen

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: January 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 19, 2010

Record last verified: 2010-01

Locations

DK (1)