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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University College, London.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
King's College London
Imperial College London
University of Nottingham
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT01106300
First received: April 16, 2010
Last updated: June 23, 2010
Last verified: June 2010

April 16, 2010
June 23, 2010
February 2009
February 2011   (final data collection date for primary outcome measure)
Cross sectional area of Rectus Femoris [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Loss of 15% of Cross sectional area over 10 days
Same as current
Complete list of historical versions of study NCT01106300 on ClinicalTrials.gov Archive Site
Not Provided
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Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation
Assessment of Peripheral Muscle and Bone Mass in the Critically Ill and Its Response to External Muscle Stimulation

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

quadricep muscle biopsy, blood and urine samples

Non-Probability Sample

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

  • Critical Illness
  • Septic Shock
  • Trauma
  • Acute Organ Failure
Not Provided
  • Multi-organ failure
    Sedated ventilated patients in multi-organ failure
  • Single-organ failure
    Sedated ventilated patients in single organ failure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Zudin Puthucheary, MRCP zudin.puthucheary.09@ucl.ac.uk
Contact: Jai Rawal, MRCS jairawal@hotmail.com
United Kingdom
 
NCT01106300
q/0505/30
Yes
Dr Nick McNally, University College London
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
University College, London
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP