Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation (MUSCLE)
Recruitment status was Recruiting
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | April 16, 2010 | ||||||||||||
| Last Updated Date | June 23, 2010 | ||||||||||||
| Start Date ICMJE | February 2009 | ||||||||||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01106300 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation | ||||||||||||
| Official Title ICMJE | Assessment of Peripheral Muscle and Bone Mass in the Critically Ill and Its Response to External Muscle Stimulation | ||||||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Retention: Samples With DNA Description: quadricep muscle biopsy, blood and urine samples |
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| 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 |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||||||
| Estimated Completion Date | December 2011 | ||||||||||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01106300 | ||||||||||||
| Other Study ID Numbers ICMJE | q/0505/30 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Dr Nick McNally, University College London | ||||||||||||
| Study Sponsor ICMJE | University College, London | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University College, London | ||||||||||||
| Verification Date | June 2010 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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