Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation

NCT01106300 | Completed DMC

• 1 other identifier: 09/0167
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 3

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.

Conditions

Critical Illness; Septic Shock; Trauma; Organ Failure

Outcome Measures

Primary Outcomes (1)

• Cross sectional area of Rectus Femoris

  Loss of 15% of Cross sectional area over 10 days

  10 days

Study Arms (2)

Multi-organ failure

Sedated ventilated patients in multi-organ failure

Single-organ failure

Sedated ventilated patients in single organ failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Ventilated patients aged \> 18 years likely to survive and remain ventilated for 48 hours and on ICU for 7 days will be recruited.

You may not qualify if:

• Those who are pregnant,
• Have active malignancy,
• Have primary muscle/bilateral lower limb disorders or
• Are unlikely to survive 48 hrs.

Sponsors & Collaborators

• University College, London: lead
• King's College London: collaborator
• Imperial College London: collaborator
• University of Nottingham: collaborator

Study Sites (3)

Whittington Hospital NHS Trust

London, London, N19 5NF, United Kingdom

Location

Kings College Hospital

London, London, SE5 9rs, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 25888496 BACKGROUND

• 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.

  PMID: 25882765 BACKGROUND

• 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.

  PMID: 24108501 RESULT

• 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.

  PMID: 24519306 RESULT

• 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.

  PMID: 29980655 DERIVED

• 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.

  PMID: 26974547 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

quadricep muscle biopsy, blood and urine samples

MeSH Terms

Conditions

Critical Illness; Shock, Septic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Study Officials

• Hugh Montgomery, MD

  University College, London

  STUDY CHAIR

• Nicholas Hart, PhD

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

  STUDY CHAIR

• Zudin Puthucheary, MRCP

  University College London, Whittington Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 19, 2010
• Study Start: February 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2014-04

Locations

GB (3)