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Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation

NCT ID: NCT01106300

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness Septic Shock Trauma Organ Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multi-organ failure

Sedated ventilated patients in multi-organ failure

No interventions assigned to this group

Single-organ failure

Sedated ventilated patients in single organ failure

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugh Montgomery, MD

Role: STUDY_CHAIR

University College, London

Nicholas Hart, PhD

Role: STUDY_CHAIR

Guy's & St Thomas' NHS Foundation Trust, Kings College London

Zudin Puthucheary, MRCP

Role: PRINCIPAL_INVESTIGATOR

University College London, Whittington Hospital NHS Trust

Locations

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Whittington Hospital NHS Trust

London, London, United Kingdom

Site Status

Kings College Hospital

London, London, United Kingdom

Site Status

Guy's & St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 25888496 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25882765 (View on PubMed)

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.

Reference Type RESULT
PMID: 24108501 (View on PubMed)

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.

Reference Type RESULT
PMID: 24519306 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29980655 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26974547 (View on PubMed)

Other Identifiers

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09/0167

Identifier Type: -

Identifier Source: org_study_id