Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation

Critical Illness Clinical Trial

— MUSCLE  

Official title:

Assessment of Peripheral Muscle and Bone Mass in the Critically Ill and Its Response to External Muscle Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106300
• Other study ID #: 09/0167
• Status: Completed
• Phase: N/A
• First received: April 16, 2010
• Last updated: December 17, 2015
• Start date: February 2009
• Est. completion date: December 2015

Study information

• Verified date: April 2014
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Organ Failure
• Septic Shock
• Trauma

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London
United Kingdom	Kings College Hospital	London
United Kingdom	Whittington Hospital NHS Trust	London

Sponsors (4)

Lead Sponsor	Collaborator
University College, London	Imperial College London, King's College London, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Puthucheary ZA, McPhail MJ, Hart N. Acute muscle wasting among critically ill patients--reply. JAMA. 2014 Feb 12;311(6):622-3. doi: 10.1001/jama.2013.285426. — View Citation

Puthucheary ZA, Phadke R, Rawal J, McPhail MJ, Sidhu PS, Rowlerson A, Moxham J, Harridge S, Hart N, Montgomery HE. Qualitative Ultrasound in Acute Critical Illness Muscle Wasting. Crit Care Med. 2015 Aug;43(8):1603-11. doi: 10.1097/CCM.0000000000001016. — View Citation

Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute — View Citation

Rawal J, McPhail MJ, Ratnayake G, Chan P, Moxham J, Harridge SD, Hart N, Montgomery HE, Puthucheary ZA. A pilot study of change in fracture risk in patients with acute respiratory distress syndrome. Crit Care. 2015 Apr 14;19:165. doi: 10.1186/s13054-015-0892-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross sectional area of Rectus Femoris	Loss of 15% of Cross sectional area over 10 days	10 days	No