Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 22, 2011
October 16, 2013
April 2011
October 2013   (final data collection date for primary outcome measure)
Change in muscle myostatin and FHL-1 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01321320 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Investigation of the Role of FHL-1 and Myostatin in Intensive Care Unit Acquired Paresis (ICUAP)
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.

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
  • Intensive Care Unit Acquired Paresis
  • Muscle Wasting
Other: Active muscle stimulation
Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned).
Experimental: Active stimulation
This group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned.
Intervention: Other: Active muscle stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • High risk patients admitted to AICU.

Exclusion Criteria:

  • Pre existing neuromuscular disease.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01321320
CRO1439
No
Prof M Polkey, Imperial College London and Royal Brompton Hospital
Imperial College London
  • Medical Research Council
  • Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: M Polkey Royal Brompton Hospital and Imperial College
Principal Investigator: Susannah Bloch Imperial College London
Imperial College London
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP