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Investigation of the Role of FHL-1 and Myostatin in Intensive Care Unit Acquired Paresis (ICUAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321320
First Posted: March 23, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medical Research Council
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
Imperial College London
  Purpose
The primary hypothesis for this study is that Myostatin and FHL-1 are important in the development of ICUAP and that changes in activity levels of muscle will modify the levels of expression and activity of these proteins.

Condition Intervention
Intensive Care Unit Acquired Paresis Muscle Wasting Other: Active muscle stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Investigation of the Role of FHL-1 and Myostatin in the Development of Intensive Care Unit Acquired Paresis (ICUAP) and the Effect of Increased Muscle Activity on These Pathways.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Change in muscle myostatin and FHL-1 [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Change in quadriceps cross sectional area [ Time Frame: 1 week ]
  • Change in quadriceps strength [ Time Frame: 1 week ]
  • Change in blood myostatin, miRNA and other markers of muscle breakdown [ Time Frame: 1 week ]
  • Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples. [ Time Frame: 1 week ]
  • Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received. [ Time Frame: 1 week ]
  • Change in muscle phenotype and change in cross sectional area for individual fiber types [ Time Frame: 1 week ]

Enrollment: 13
Study Start Date: April 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active stimulation
This group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned.
Other: Active muscle stimulation
Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned).

Detailed Description:
ICUAP is an increasingly recognised clinical problem associated with significant morbidity and mortality. However the pathogenesis of the diseae is poorly understood and as yet no treatment exists. We believe that both myostatin and FHL-1 will be important in the development of this disease. This is based recent research and that both these proteins are likely to be regulated by sepsis and immobility (two major risk factors for ICUAP. There is evidence from invitro work that the two are likely to interact. We have designed an interventional trial to investigate the above hypothesis. Patients admitted to ICU and at risk of developing muscle wasting will be selected and receive electrical muscle stimulation of the quadriceps muscle for 1 week. Physiological measurements of peripheral and respiratory muscle strength and quadriceps size will be made pre and post intervention. And muscle biopsies, blood and urine collected from both legs pre and post intervention. The relevant molecular pathways can then be examined.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High risk patients admitted to AICU.

Exclusion Criteria:

  • Pre existing neuromuscular disease.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321320


Locations
United Kingdom
National Heart and Lung Institute, Imperial College
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Medical Research Council
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: M Polkey Royal Brompton Hospital and Imperial College
Principal Investigator: Susannah Bloch Imperial College London
  More Information

Responsible Party: Prof M Polkey, Imperial College London and Royal Brompton Hospital
ClinicalTrials.gov Identifier: NCT01321320     History of Changes
Other Study ID Numbers: CRO1439
First Submitted: March 22, 2011
First Posted: March 23, 2011
Last Update Posted: October 12, 2017
Last Verified: October 2013

Keywords provided by Imperial College London:
ICUAP
Critical illness
Muscle wasting
ICU

Additional relevant MeSH terms:
Cachexia
Wasting Syndrome
Paresis
Muscle Weakness
Muscular Atrophy
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Neurologic Manifestations
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes
Atrophy
Pathological Conditions, Anatomical