Clinical trial NCT01106300: Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation
Official title: Assessment of Peripheral Muscle and Bone Mass in the Critically Ill and Its Response to External Muscle Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Septic Shock
Trauma
Organ Failure
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: King's College London
name: Imperial College London
name: University of Nottingham
First posted: 2010-04-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cross sectional area of Rectus Femoris
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Whittington Hospital NHS Trust
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: University College, London
name: Hugh Montgomery, MD
role: STUDY_CHAIR
affiliation: Guy's & St Thomas' NHS Foundation Trust, Kings College London
name: Nicholas Hart, PhD
role: STUDY_CHAIR
affiliation: University College London, Whittington Hospital NHS Trust
name: Zudin Puthucheary, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
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(1):165. doi: 10.1186/s13054-015-0892-y.
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.
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 skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.
citation: 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. No abstract available.
citation: Puthucheary ZA, Astin R, Mcphail MJW, Saeed S, Pasha Y, Bear DE, Constantin D, Velloso C, Manning S, Calvert L, Singer M, Batterham RL, Gomez-Romero M, Holmes E, Steiner MC, Atherton PJ, Greenhaff P, Edwards LM, Smith K, Harridge SD, Hart N, Montgomery HE. Metabolic phenotype of skeletal muscle in early critical illness. Thorax. 2018 Oct;73(10):926-935. doi: 10.1136/thoraxjnl-2017-211073. Epub 2018 Jul 6.
citation: McNelly AS, Rawal J, Shrikrishna D, Hopkinson NS, Moxham J, Harridge SD, Hart N, Montgomery HE, Puthucheary ZA. An Exploratory Study of Long-Term Outcome Measures in Critical Illness Survivors: Construct Validity of Physical Activity, Frailty, and Health-Related Quality of Life Measures. Crit Care Med. 2016 Jun;44(6):e362-9. doi: 10.1097/CCM.0000000000001645.