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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01321320
Enrollment
13
Registered
2011-03-23
Start date
2011-04-30
Completion date
2013-10-31
Last updated
2013-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Acquired Paresis, Muscle Wasting

Keywords

ICUAP, Critical illness, Muscle wasting, ICU

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.

Interventions

OTHERActive muscle stimulation

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

Sponsors

Imperial College London
Lead SponsorOTHER
Medical Research Council
CollaboratorOTHER_GOV
Royal Brompton & Harefield NHS Foundation Trust
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* High risk patients admitted to AICU.

Exclusion criteria

* Pre existing neuromuscular disease.

Design outcomes

Primary

MeasureTime frame
Change in muscle myostatin and FHL-11 week

Secondary

MeasureTime frame
Change in quadriceps strength1 week
Change in blood myostatin, miRNA and other markers of muscle breakdown1 week
Change in quadriceps cross sectional area1 week
Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.1 week
Change in muscle phenotype and change in cross sectional area for individual fiber types1 week
Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.1 week

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026