Septic ShockNCT01071343
Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients
A study testing Transcutaneous electrical muscle stimulation in people with Septic Shock, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Transcutaneous electrical muscle stimulation
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with septic shock admitted to the ICU of Rigshospitalet
- written informed consent from patient or proxy
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Intensive Care, Rigshospitalet, University of Copenhagen
Copenhagen, 2100
About this study
Official title: Effect of Transcutaneous Electric Muscle Stimulation on Muscle Volume in Patients With Septic Shock
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.
Read the 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
- Being tested
- Transcutaneous electrical muscle stimulation
- Keywords
- muscular atrophy, recovery of function, rehabilitation, Intensive care unit
- Medical subject headings
- Shock, Septic, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical muscle stimulationDevice
After randomization of the quadriceps muscles TEMS is applied on the intervention side for 7 consecutive days, 60 minutes per day.
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startJan 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Investigators
- Jesper B Poulsen, MD, Principal investigator, Rigshospitalet, University of CopenhagenKirsten Møller, MD, PhD, DMSci, Study chair, Rigshospitalet, University of CopenhagenAnders Perner, MD, PhD, Study chair, Rigshospitalet, University of CopenhagenHenrik Kehlet, MD, DMSci, Study chair, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071343
- Sponsor's protocol ID
- H-KF-283379
- Status last verified
- Jan 2010
- First submitted
- 18 Feb 2010
- Last updated
- 19 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electric Muscle Stimulation on Muscle Volume in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT01071343
- Acronym / sponsor ID
- H-KF-283379
- Conditions
- Septic Shock
- Keywords
- muscular atrophy, recovery of function, rehabilitation, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jan 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with septic shock admitted to the ICU of Rigshospitalet
- written informed consent from patient or proxy
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical muscle stimulationAfter randomization of the quadriceps muscles TEMS is applied on the intervention side for 7 consecutive days, 60 minutes per day. | Device | – |
Primary outcome
Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2010.
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical muscle stimulation in people with Septic Shock, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of quadriceps muscles were calculated after 3-D reconstruction based on CT scans. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2010.