Investigation of the Role of FHL-1 and Myostatin in Intensive Care Unit Acquired Paresis (ICUAP)
Primary Purpose
Intensive Care Unit Acquired Paresis, Muscle Wasting
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Active muscle stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Intensive Care Unit Acquired Paresis focused on measuring ICUAP, Critical illness, Muscle wasting, ICU
Eligibility Criteria
Inclusion Criteria:
- High risk patients admitted to AICU.
Exclusion Criteria:
- Pre existing neuromuscular disease.
Sites / Locations
- National Heart and Lung Institute, Imperial College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active stimulation
Arm Description
This group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned.
Outcomes
Primary Outcome Measures
Change in muscle myostatin and FHL-1
Secondary Outcome Measures
Change in quadriceps cross sectional area
Change in quadriceps strength
Change in blood myostatin, miRNA and other markers of muscle breakdown
Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.
Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.
Change in muscle phenotype and change in cross sectional area for individual fiber types
Full Information
NCT ID
NCT01321320
First Posted
March 22, 2011
Last Updated
October 16, 2013
Sponsor
Imperial College London
Collaborators
Medical Research Council, Royal Brompton & Harefield NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01321320
Brief Title
Investigation of the Role of FHL-1 and Myostatin in Intensive Care Unit Acquired Paresis (ICUAP)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Imperial College London
Collaborators
Medical Research Council, Royal Brompton & Harefield NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Acquired Paresis, Muscle Wasting
Keywords
ICUAP, Critical illness, Muscle wasting, ICU
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active stimulation
Arm Type
Experimental
Arm Description
This group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned.
Intervention Type
Other
Intervention Name(s)
Active muscle stimulation
Intervention Description
Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned).
Primary Outcome Measure Information:
Title
Change in muscle myostatin and FHL-1
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change in quadriceps cross sectional area
Time Frame
1 week
Title
Change in quadriceps strength
Time Frame
1 week
Title
Change in blood myostatin, miRNA and other markers of muscle breakdown
Time Frame
1 week
Title
Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.
Time Frame
1 week
Title
Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.
Time Frame
1 week
Title
Change in muscle phenotype and change in cross sectional area for individual fiber types
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
High risk patients admitted to AICU.
Exclusion Criteria:
Pre existing neuromuscular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Polkey
Organizational Affiliation
Royal Brompton Hospital and Imperial College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susannah Bloch
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Heart and Lung Institute, Imperial College
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Investigation of the Role of FHL-1 and Myostatin in Intensive Care Unit Acquired Paresis (ICUAP)
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