SepsisNCT00735384
Muscle Force Assessment in the Intensive Care Unit and in Primary Myopathies
An observational study of Sepsis and Primary Myopathies, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The primary aim of the project is to apply the non-invasive stimulated muscle force assessment system to i) intensive care unit patients and ii) patients with primary myopathy or subclinic myopathy (e.g., Duchenne muscular dystrophy, Myotonia, MH). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Primary Myopathies
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2006to 30 Dec 2019
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Any patient which fulfills the criteria for sepsis / septic shock according the definition of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference
- Patients who will be sedated, mechanically ventilated, and immobilized
- Patients will be intubated the day of admission to ICU and started mechanically ventilated on a positive pressure ventilation modus
- The severity of each patient¢s illness will be assessed using the Acute Physiology and Chronic Health Evaluation (APACHE) II score with required entry scores of a minimum of 15-20 Points
- Patients suffering from a primary myopathy, e.g., Duchenne Muscular Dystrophy or subclinic myopathy, e.g. Malignant Hyperthermia.
Who cannot join
- Patients with neuropathies, consuming diseases in an advanced state (metastatic cancer) and severe infectious diseases (e.g. AIDS, Hepatitis), as well as patients with injured legs and/or patients requiring neuromuscular blocking drugs.
- Patients under the age of 18 yr.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Methodology of Non-invasive Stimulated Muscle Force Assessment to ICU Patients and Patients With Primary Myopathies to Characterize Their Muscle Weakness - Extension of the Study Protocol: 2008 to 2018
The primary aim of the project is to apply the non-invasive stimulated muscle force assessment system to i) intensive care unit patients and ii) patients with primary myopathy or subclinic myopathy (e.g., Duchenne muscular dystrophy, Myotonia, MH). The investigators will use this new methodology of force assessment to phenotype patients weakness during their illnesses (depict typical force pattern) and monitor recovery periods, or disease progression, respectively. This new system will be evaluated until the year 2018. The investigators will determine variables of isometric skeletal muscle force.
These systems should serve as force monitoring tools and help to guide therapies.
Read the detailed description
A force measuring system similar to one employed in previous studies will be redesigned with a new stimulator system and leg support system. This new, small, light and portable measurement system accurately measures patients' muscle forces. The system produces repeatable results. Over a long-time time period, this system will be applied to ICU patients and patients with primary myopathies, e.g. muscular dystrophy Duchenne or myotonias, and their ankle dorsiflexor isometric torques measured after electrical peroneal nerve stimulation. Torques will be amplified and converted into electrical signals by a Whetstone bridge, and data will be stored on a computer (LabView system). Stimulated torque responses will be obtained regularly, and subsequently the individualized curves will be determined. Electromyogram will be performed at each recording session. For all subjects possible, the investigators will continue to monitor their stimulated muscle forces during their recovery periods or disease progression. Type of data: Variables of isometric skeletal muscle contractions, such as peak torques, contraction and relaxation times and torque latencies. To find an assumed difference of 50% in strength, at least 30 individuals (power 0.9) are required.
Values will be compared to patients voluntary forces, determined by Muscle Research Council (MRC) and Manual Muscle Test (MMT) scores.
Additionally, skin resistances of edema patients will by determined employing a twitch stimulator and an oscilloscope. We are interested whether edema (fluid) changes tissue resistance. Data are required to redesign the new stimulation unit of the muscle force measuring system.
- Conditions
- Sepsis, Primary Myopathies
- Keywords
- sepsis, critical illness, muscle, skeletal, myopathy, isometric contraction, intensive care units, torque, muscular atrophy, malignant hyperthermia, skin resistance
- Medical subject headings
- Sepsis, Critical Illness, Muscular Diseases, Muscular Atrophy, Malignant Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with critical illness myopathy | Patients with,e.g., sepsis, with secondary myopathy | |
| Patients with Primary Myopathies | Patients with primary myopathy, e.g., Duchenne Muscular Dystrophy, Myotonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Force in ICU Patients and Patients with Primary Myopathies
Characterisation and follow up of the muscle force of the lower leg in severly ill patients of a intensive-care-unit. To characterise primary myopathy patients typical force pattern of the lower leg and to follow up their individual disease progression over many years
Measured: ICU patients: 1-3 months; Myopathy patients: up to 5 years
Secondary outcomes (1)
Muscle forces pending on the Malignant Hyperthermia (MH) status of a patient (susceptible to MH or not susceptible to MH)
Measured: at the time point of MH testing, i.e., at hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study start1 Sep 2006
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Albert Urwyler, Professor MD, Study director, Departments of Anaesthesia and Research, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735384
- Sponsor's protocol ID
- 134/02
- Other IDs
- P21/08//A05/08
- Status last verified
- Nov 2021
- First submitted
- 13 Aug 2008
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Ginz HF, Iaizzo PA, Urwyler A, Pargger H. Use of non-invasive-stimulated muscle force assessment in long-term critically ill patients: a future standard in the intensive care unit? Acta Anaesthesiol Scand. 2008 Jan;52(1):20-7. doi: 10.1111/j.1399-6576.2007.01427.x. Epub 2007 Aug 20.
PubMed 17714574Ginz HF, Bandschapp O, Urwyler A, Girard T, Iaizzo PA. Tissue oedema is not associated with skeletal muscle weakness in septic patients. Acta Anaesthesiol Scand. 2010 Aug;54(7):904. doi: 10.1111/j.1399-6576.2010.02257.x. No abstract available.
PubMed 20649524Durfee WK, Young JR, Ginz HF. Inter-electrode tissue resistance is not affected by tissue oedema when electrically stimulating the lower limb of sepsis patients. J Med Eng Technol. 2014 May;38(4):227-31. doi: 10.3109/03091902.2014.904451.
PubMed 24758395Ginz HF, Iaizzo PA, Schweikert K, Durfee WK. Isometric skeletal muscle force measurement in primary myopathies. Muscle Nerve. 2016 Jun;53(6):913-7. doi: 10.1002/mus.24954. Epub 2016 Feb 8.
PubMed 26506402Ginz HF, Iaizzo PA, Schweikert K, Durfee WK. Long-term monitoring of stimulated lower leg skeletal muscle forces compared with voluntary contractions in myopathy patients - A five-year follow-up report on 5 adults. J Bodyw Mov Ther. 2024 Apr;38:8-12. doi: 10.1016/j.jbmt.2024.01.011. Epub 2024 Jan 23.
PubMed 38763619
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Methodology of Non-invasive Stimulated Muscle Force Assessment to ICU Patients and Patients With Primary Myopathies to Characterize Their Muscle Weakness - Extension of the Study Protocol: 2008 to 2018
- ClinicalTrials.gov ID
- NCT00735384
- Acronym / sponsor ID
- 134/02
- Conditions
- Sepsis, Primary Myopathies
- Keywords
- sepsis, critical illness, muscle, skeletal, myopathy, isometric contraction, intensive care units, torque, muscular atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 1 Sep 2006 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 14 Aug 2008 (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.
The primary aim of the project is to apply the non-invasive stimulated muscle force assessment system to i) intensive care unit patients and ii) patients with primary myopathy or subclinic myopathy (e.g., Duchenne muscular dystrophy, Myotonia, MH). The investigators will use this new methodology of force assessment to phenotype patients weakness during their illnesses (depict typical force pattern) and monitor recovery periods, or disease progression, respectively. This new system will be evaluated until the year 2018. The investigators will determine variables of isometric skeletal muscle force.
These systems should serve as force monitoring tools and help to guide therapies.
Detailed description
A force measuring system similar to one employed in previous studies will be redesigned with a new stimulator system and leg support system. This new, small, light and portable measurement system accurately measures patients' muscle forces. The system produces repeatable results. Over a long-time time period, this system will be applied to ICU patients and patients with primary myopathies, e.g. muscular dystrophy Duchenne or myotonias, and their ankle dorsiflexor isometric torques measured after electrical peroneal nerve stimulation. Torques will be amplified and converted into electrical signals by a Whetstone bridge, and data will be stored on a computer (LabView system). Stimulated torque responses will be obtained regularly, and subsequently the individualized curves will be determined. Electromyogram will be performed at each recording session. For all subjects possible, the investigators will continue to monitor their stimulated muscle forces during their recovery periods or disease progression. Type of data: Variables of isometric skeletal muscle contractions, such as peak torques, contraction and relaxation times and torque latencies. To find an assumed difference of 50% in strength, at least 30 individuals (power 0.9) are required.
Values will be compared to patients voluntary forces, determined by Muscle Research Council (MRC) and Manual Muscle Test (MMT) scores.
Additionally, skin resistances of edema patients will by determined employing a twitch stimulator and an oscilloscope. We are interested whether edema (fluid) changes tissue resistance. Data are required to redesign the new stimulation unit of the muscle force measuring system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with critical illness myopathy | – | –Patients with,e.g., sepsis, with secondary myopathy |
| Patients with Primary Myopathies | – | –Patients with primary myopathy, e.g., Duchenne Muscular Dystrophy, Myotonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (5 listed)
- Any patient which fulfills the criteria for sepsis / septic shock according the definition of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference
- Patients who will be sedated, mechanically ventilated, and immobilized
- Patients will be intubated the day of admission to ICU and started mechanically ventilated on a positive pressure ventilation modus
- The severity of each patient¢s illness will be assessed using the Acute Physiology and Chronic Health Evaluation (APACHE) II score with required entry scores of a minimum of 15-20 Points
- Patients suffering from a primary myopathy, e.g., Duchenne Muscular Dystrophy or subclinic myopathy, e.g. Malignant Hyperthermia.
Key exclusion criteria (2 listed)
- Patients with neuropathies, consuming diseases in an advanced state (metastatic cancer) and severe infectious diseases (e.g. AIDS, Hepatitis), as well as patients with injured legs and/or patients requiring neuromuscular blocking drugs.
- Patients under the age of 18 yr.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skeletal Muscle Force in ICU Patients and Patients with Primary Myopathies
Time frame: ICU patients: 1-3 months; Myopathy patients: up to 5 years
Characterisation and follow up of the muscle force of the lower leg in severly ill patients of a intensive-care-unit. To characterise primary myopathy patients typical force pattern of the lower leg and to follow up their individual disease progression over many years
1 secondary outcome
Muscle forces pending on the Malignant Hyperthermia (MH) status of a patient (susceptible to MH or not susceptible to MH)
Time frame: at the time point of MH testing, i.e., at hospital admission
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 29 Nov 2021.
- Results publication: PubMed 17714574Ginz HF, Iaizzo PA, Urwyler A, Pargger H. Use of non-invasive-stimulated muscle force assessment in long-term critically ill patients: a future standard in the intensive care unit? Acta Anaesthesiol Scand. 2008 Jan;52(1):20-7. doi: 10.1111/j.1399-6576.2007.01427.x. Epub 2007 Aug 20.
- Results publication: PubMed 20649524Ginz HF, Bandschapp O, Urwyler A, Girard T, Iaizzo PA. Tissue oedema is not associated with skeletal muscle weakness in septic patients. Acta Anaesthesiol Scand. 2010 Aug;54(7):904. doi: 10.1111/j.1399-6576.2010.02257.x. No abstract available.
- Results publication: PubMed 24758395Durfee WK, Young JR, Ginz HF. Inter-electrode tissue resistance is not affected by tissue oedema when electrically stimulating the lower limb of sepsis patients. J Med Eng Technol. 2014 May;38(4):227-31. doi: 10.3109/03091902.2014.904451.
- Results publication: PubMed 26506402Ginz HF, Iaizzo PA, Schweikert K, Durfee WK. Isometric skeletal muscle force measurement in primary myopathies. Muscle Nerve. 2016 Jun;53(6):913-7. doi: 10.1002/mus.24954. Epub 2016 Feb 8.
- Derived from this study: PubMed 38763619Ginz HF, Iaizzo PA, Schweikert K, Durfee WK. Long-term monitoring of stimulated lower leg skeletal muscle forces compared with voluntary contractions in myopathy patients - A five-year follow-up report on 5 adults. J Bodyw Mov Ther. 2024 Apr;38:8-12. doi: 10.1016/j.jbmt.2024.01.011. Epub 2024 Jan 23.
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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.
Albert Urwyler, Professor MD study director
Departments of Anaesthesia and Research, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Primary Myopathies, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 2 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 29 Nov 2021. 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 Switzerland. 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?
Skeletal Muscle Force in ICU Patients and Patients with Primary Myopathies (time frame: ICU patients: 1-3 months; Myopathy patients: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735384, which also lists 5 linked publications.
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 29 Nov 2021.