Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation (MUSCLE)
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Critical Illness Septic Shock Trauma Acute Organ Failure |
| Study Type: | Observational |
| Study Design: | 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 |
- 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
Biospecimen Retention: Samples With DNA
quadricep muscle biopsy, blood and urine samples
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Multi-organ failure
Sedated ventilated patients in multi-organ failure
|
|
Single-organ failure
Sedated ventilated patients in single organ failure
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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
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| Contact: Zudin Puthucheary, MRCP | zudin.puthucheary.09@ucl.ac.uk | |
| Contact: Jai Rawal, MRCS | jairawal@hotmail.com |
| United Kingdom | |
| Guy's & St Thomas' NHS Foundation Trust | Not yet recruiting |
| London, United Kingdom, SE1 7EH | |
| Contact: Nicholas Hart, Phd nicholas.hart@gstt.nhs.uk | |
| Kings College Hospital | Recruiting |
| London, United Kingdom, SE5 9rs | |
| Contact: John Moxham, MD j.moxham@nhs.net | |
| Whittington Hospital NHS Trust | Recruiting |
| London, United Kingdom, N19 5NF | |
| Contact: Hugh Montgomery, MD h.montgomery@ucl.ac.uk | |
| 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
No publications provided
| Responsible Party: | Dr Nick McNally, University College London |
| ClinicalTrials.gov Identifier: | NCT01106300 History of Changes |
| Other Study ID Numbers: | q/0505/30 |
| Study First Received: | April 16, 2010 |
| Last Updated: | June 23, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Critical Illness Shock Shock, Septic Disease Attributes Pathologic Processes |
Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation |
ClinicalTrials.gov processed this record on May 19, 2013