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

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01321320
First received: March 22, 2011
Last updated: October 16, 2013
Last verified: October 2013
  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 Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in quadriceps cross sectional area [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Change in quadriceps strength [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Change in blood myostatin, miRNA and other markers of muscle breakdown [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Change in muscle phenotype and change in cross sectional area for individual fiber types [ Time Frame: 1 week ] [ Designated as safety issue: No ]

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

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

Inclusion Criteria:

  • High risk patients admitted to AICU.

Exclusion Criteria:

  • Pre existing neuromuscular disease.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof M Polkey, Imperial College London and Royal Brompton Hospital
ClinicalTrials.gov Identifier: NCT01321320     History of Changes
Other Study ID Numbers: CRO1439
Study First Received: March 22, 2011
Last Updated: October 16, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Muscular Atrophy
Paresis
Muscle Weakness
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014