Muscle Force Assessment in the Intensive Care Unit and in Primary Myopathies

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00735384
First received: August 13, 2008
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

The primary aim of the project is to apply the redesigned non-invasive stimulated muscle force assessment system to intensive care unit patients and 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 recovery periods. This new system will be evaluated until the year 2016. The investigators will measure parameters of isometric skeletal muscle force. An anonymized data bank is built up at the University of Minnesota in Minneapolis.

These systems should serve as force monitoring tools and help to guide therapies.


Condition
Sepsis
Primary Myopathies

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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 2016

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Skeletal Muscle Force in ICU Patients and Patients with Primary Myopathies [ Time Frame: ICU patients: 1-3 months; Myopathy patients: up to 4 years ] [ Designated as safety issue: No ]
    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 a couple of years


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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 (aluminium). An electromyogram will be combined. This new, small, light and portable measurement system accurately measures patients' muscle forces. The system produces repeatable results. Over a time period of 9 years, this new 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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735384

Contacts
Contact: Albert Urwyler, Professor MD +4161 265 2525 Albert.Urwyler@usb.ch
Contact: Hans F Ginz, MD +49 7621 41678600 hans.ginz@unibas.ch

Locations
Switzerland
University of Basel Hospital Recruiting
Basel, Switzerland, CH-4031
Contact: Albert Urwyler, Professor       Albert.Urwyler@usb.ch   
Contact: Hans F Ginz, MD    +49 7621 4168296    hans.ginz@unibas.ch   
Principal Investigator: Albert Urwyler, Professor MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Minnesota - Clinical and Translational Science Institute
Investigators
Study Director: Albert Urwyler, Professor MD Departments of Anaesthesia and Research, University of Basel Hospital, CH-4031, Switzerland
  More Information

Publications:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00735384     History of Changes
Other Study ID Numbers: 134/02, P21/08//A05/08
Study First Received: August 13, 2008
Last Updated: April 28, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
sepsis
critical illness
muscle, skeletal
myopathy
isometric contraction
intensive care units
torque
muscular atrophy
malignant hyperthermia
skin resistance

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014