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

Not Applicable

Completed

• Conditions: Intensive Care Unit Acquired Paresis; Muscle Wasting
• Interventions: Other: Active muscle stimulation

• Registration Number: NCT01321320
• Lead Sponsor: Imperial College London

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.

Study Timeline

• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Study Start: 2011-04
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-16
• Last Update Posted: 2013-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• High risk patients admitted to AICU.

Exclusion Criteria

• Pre existing neuromuscular disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active stimulation	Active muscle stimulation	This group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned.

Primary Outcome Measures

Name	Time	Method
Change in muscle myostatin and FHL-1	1 week

Secondary Outcome Measures

Name	Time	Method
Change in blood myostatin, miRNA and other markers of muscle breakdown	1 week
Change in quadriceps cross sectional area	1 week
Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.	1 week
Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.	1 week
Change in quadriceps strength	1 week
Change in muscle phenotype and change in cross sectional area for individual fiber types	1 week

Trial Locations

Locations (1)

National Heart and Lung Institute, Imperial College; 🇬🇧 London, United Kingdom