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NCT Number: NCT01321320

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

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.

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Key information

Conditions

Intensive Care Unit Acquired Paresis Atrophy Critical Illness Disease Attributes Muscle Wasting Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Heart and Lung Institute, Imperial College

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • High risk patients admitted to AICU.

Exclusion criteria

  • Pre existing neuromuscular disease.

Treatment and study plan

Active muscle stimulation

Other

Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned).

Primary outcomes

  1. Change in muscle myostatin and FHL-1

    Time frame: 1 week

Secondary outcomes

  1. Change in quadriceps cross sectional area

    Time frame: 1 week

  2. Change in quadriceps strength

    Time frame: 1 week

  3. Change in blood myostatin, miRNA and other markers of muscle breakdown

    Time frame: 1 week

  4. Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.

    Time frame: 1 week

  5. Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.

    Time frame: 1 week

  6. Change in muscle phenotype and change in cross sectional area for individual fiber types

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Medical Research Council
  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 23, 2011
Registry last updated
Oct 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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