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Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation (MUSCLE)

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ClinicalTrials.gov Identifier: NCT01106300
Recruitment Status : Completed
First Posted : April 19, 2010
Last Update Posted : December 18, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Each year, 110,000 English/Welsh patients are admitted to Intensive Care Units (ICU). Many face prolonged disability as a result. Over two thirds have moderate-extreme limitation in their usual activity a year later, and one-third are severely affected, being unable to continue "most activities," or to live independently. Quite why known- but severe muscle wasting isn't may play an important role. We hope to find out, measuring the degree of wasting in patients, and seeking potential causes. We shall also address the mechanism of wasting, which may reflect an altered balance of activity in muscle growth pathways and those that break muscle down. We'll do this by collecting data, taking regular blood tests, scanning the leg muscles with an ultrasound machine, and analysing small muscle samples. In addition, we'll accurately and objectively measure how impaired these patients become, using specialist questionnaires, special monitoring equipment, simple walking tests and occasional special ('Cardio-Pulmonary') exercise tests. We'll try to see how badly activity is limited, and tease out whether muscle weakness plays a significant role in this. Finally, keeping muscles working (hard to do when unconscious/drowsy/bed-bound) may maintain muscle mass, so we'll see whether maintaining muscle activity using painless electrical stimulation will help.

Condition or disease
Critical Illness Septic Shock Trauma Organ Failure

Study Design

Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Peripheral Muscle and Bone Mass in the Critically Ill and Its Response to External Muscle Stimulation
Study Start Date : February 2009
Primary Completion Date : December 2015
Study Completion Date : December 2015
Groups and Cohorts

Multi-organ failure
Sedated ventilated patients in multi-organ failure
Single-organ failure
Sedated ventilated patients in single organ failure

Outcome Measures

Primary Outcome Measures :
  1. Cross sectional area of Rectus Femoris [ Time Frame: 10 days ]
    Loss of 15% of Cross sectional area over 10 days

Biospecimen Retention:   Samples With DNA
quadricep muscle biopsy, blood and urine samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All admission to CRitical care who are ventilated, and are likely to remain so for 48hrs or more AND remain on ITU for 7 days

Inclusion Criteria:

  • Ventilated patients aged > 18 years likely to survive and remain ventilated for 48 hours and on ICU for 7 days will be recruited.

Exclusion Criteria:

  • Those who are pregnant,
  • Have active malignancy,
  • Have primary muscle/bilateral lower limb disorders or
  • Are unlikely to survive 48 hrs.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106300

United Kingdom
Whittington Hospital NHS Trust
London, United Kingdom, N19 5NF
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Kings College Hospital
London, United Kingdom, SE5 9rs
Sponsors and Collaborators
University College, London
King's College London
Imperial College London
University of Nottingham
Study Chair: Hugh Montgomery, MD University College, London
Study Chair: Nicholas Hart, PhD Guy's & St Thomas' NHS Foundation Trust, Kings College London
Principal Investigator: Zudin Puthucheary, MRCP University College London, Whittington Hospital NHS Trust
More Information

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01106300     History of Changes
Other Study ID Numbers: 09/0167
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: April 2014

Additional relevant MeSH terms:
Shock, Septic
Critical Illness
Systemic Inflammatory Response Syndrome
Pathologic Processes
Disease Attributes