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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01106300
Other study ID # 09/0167
Secondary ID
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


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
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