MedDataX Logo

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

NCT ID: NCT01321320

Last Updated: 2013-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intensive Care Unit Acquired Paresis Muscle Wasting

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ICUAP Critical illness Muscle wasting ICU

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active stimulation

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

Group Type EXPERIMENTAL

Active muscle stimulation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Active muscle stimulation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* High risk patients admitted to AICU.

Exclusion Criteria

* Pre existing neuromuscular disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical Research Council

OTHER_GOV

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Imperial College London and Royal Brompton Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

M Polkey

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton Hospital and Imperial College

Susannah Bloch

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Heart and Lung Institute, Imperial College

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRO1439

Identifier Type: -

Identifier Source: org_study_id