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Search / Trial NCT01071343

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

Muscular Atrophy Recovery Of Function Rehabilitation Intensive Care Unit

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.

Locations

Copenhagen, , Denmark

Patients applied

0 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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