Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients
Launched by RIGSHOSPITALET, DENMARK · Feb 18, 2010
Trial Information
Current as of June 04, 2025
Completed
Keywords
ClinConnect Summary
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 undergoe...
Gender
ALL
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
About Rigshospitalet, Denmark
Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Patients applied
Trial Officials
Jesper B Poulsen, MD
Principal Investigator
Rigshospitalet, University of Copenhagen
Kirsten Møller, MD, PhD, DMSci
Study Chair
Rigshospitalet, University of Copenhagen
Anders Perner, MD, PhD
Study Chair
Rigshospitalet, University of Copenhagen
Henrik Kehlet, MD, DMSci
Study Chair
Rigshospitalet, University of Copenhagen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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