Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation (MUSCLE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University College, London
Sponsor:
Collaborators:
King's College London
Imperial College London
University of Nottingham
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01106300
First received: April 16, 2010
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition
Critical Illness
Septic Shock
Trauma
Organ Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Peripheral Muscle and Bone Mass in the Critically Ill and Its Response to External Muscle Stimulation

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Cross sectional area of Rectus Femoris [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Loss of 15% of Cross sectional area over 10 days


Biospecimen Retention:   Samples With DNA

quadricep muscle biopsy, blood and urine samples


Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Multi-organ failure
Sedated ventilated patients in multi-organ failure
Single-organ failure
Sedated ventilated patients in single organ failure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106300

Contacts
Contact: Zudin Puthucheary, MRCP zudin.puthucheary.09@ucl.ac.uk
Contact: Jai Rawal, MRCS jairawal@hotmail.com

Locations
United Kingdom
Guy's & St Thomas' NHS Foundation Trust Not yet recruiting
London, United Kingdom, SE1 7EH
Contact: Nicholas Hart, Phd       nicholas.hart@gstt.nhs.uk   
Kings College Hospital Recruiting
London, United Kingdom, SE5 9rs
Contact: John Moxham, MD       j.moxham@nhs.net   
Whittington Hospital NHS Trust Recruiting
London, United Kingdom, N19 5NF
Contact: Hugh Montgomery, MD       h.montgomery@ucl.ac.uk   
Sponsors and Collaborators
University College, London
King's College London
Imperial College London
University of Nottingham
Investigators
Study Chair: Hugh Montgomery, MD University College, London
Study Chair: Nicholas Hart, PhD Guy's & St Thomas' NHS Foundation Trust, Kings College London
Principal Investigator: Zudin Puthucheary, MRCP University College London, Whittington Hospital NHS Trust
  More Information

Publications:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01106300     History of Changes
Other Study ID Numbers: q/0505/30
Study First Received: April 16, 2010
Last Updated: April 28, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Critical Illness
Shock
Shock, Septic
Disease Attributes
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on July 26, 2014