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

Muscle Wasting Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321320
• Other study ID #: CRO1439
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: October 16, 2013
• Start date: April 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• High risk patients admitted to AICU.

Exclusion Criteria:

• Pre existing neuromuscular disease.

Related Conditions & MeSH terms

• Cachexia
• Intensive Care Unit Acquired Paresis
• Muscle Wasting
• Muscle Weakness
• Muscular Atrophy
• Paresis

Intervention

Other:
• Active muscle stimulation
Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned).

Locations

Country	Name	City	State
United Kingdom	National Heart and Lung Institute, Imperial College	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Medical Research Council, Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle myostatin and FHL-1		1 week
Secondary	Change in quadriceps cross sectional area		1 week
Secondary	Change in quadriceps strength		1 week
Secondary	Change in blood myostatin, miRNA and other markers of muscle breakdown		1 week
Secondary	Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.		1 week
Secondary	Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.		1 week
Secondary	Change in muscle phenotype and change in cross sectional area for individual fiber types		1 week