Intensive Care Unit Acquired ParesisNCT01321320
Investigation of the Role of FHL-1 and Myostatin in Intensive Care Unit Acquired Paresis (ICUAP)
A study testing Active muscle stimulation in people with Intensive Care Unit Acquired Paresis and Muscle Wasting, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Acquired Paresis, Muscle Wasting
- What is being tested?
- Active muscle stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk patients admitted to AICU.
Who cannot join
- Pre existing neuromuscular disease.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Heart and Lung Institute, Imperial College
London
About this study
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.
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.
Read the 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.
- Being tested
- Active muscle stimulation
- Keywords
- ICUAP, Critical illness, Muscle wasting, ICU
- Medical subject headings
- Muscular Atrophy, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active muscle stimulationOther
Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned).
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | This group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned. Receives: Other: Active muscle stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle myostatin and FHL-1
Measured: 1 week
Secondary outcomes (6)
Change in quadriceps cross sectional area
Measured: 1 week
Change in quadriceps strength
Measured: 1 week
Change in blood myostatin, miRNA and other markers of muscle breakdown
Measured: 1 week
Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.
Measured: 1 week
Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.
Measured: 1 week
Change in muscle phenotype and change in cross sectional area for individual fiber types
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit Acquired ParesisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Royal Brompton & Harefield NHS Foundation Trust
- Investigators
- M Polkey, Principal investigator, Royal Brompton Hospital and Imperial CollegeSusannah Bloch, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321320
- Sponsor's protocol ID
- CRO1439
- Status last verified
- Oct 2013
- First submitted
- 22 Mar 2011
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01321320
- Acronym / sponsor ID
- CRO1439
- Keywords
- ICUAP, Critical illness, Muscle wasting, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Apr 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Other: Active muscle stimulationThis group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- High risk patients admitted to AICU.
Key exclusion criteria (1 listed)
- Pre existing neuromuscular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active muscle stimulationNeuromuscular Electrical stimulation will be applied to one leg (randomly assigned). | Other | Active stimulation |
Primary outcome
Change in muscle myostatin and FHL-1
Time frame: 1 week
6 secondary outcomes
Change in quadriceps cross sectional area
Time frame: 1 week
Change in quadriceps strength
Time frame: 1 week
Change in blood myostatin, miRNA and other markers of muscle breakdown
Time frame: 1 week
Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.
Time frame: 1 week
Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.
Time frame: 1 week
Change in muscle phenotype and change in cross sectional area for individual fiber types
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2013.
Related trials for Intensive Care Unit Acquired Paresis
RecruitingObservational study
Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation
Intensive Care Unit Acquired Weakness, Muscle Weakness
Active, not recruiting
Assessing The Effects of Exercise, Protein, and Electric Stimulation On Intensive Care Unit Patients Outcomes
Muscle Weakness, Critical Illness
RecruitingObservational study
Muscle Recovery After Critical Illness
ICU Acquired Weakness, Post Intensive Care Unit Syndrome
RecruitingObservational study
Recovery of Physical Function After Critical Illness In Older Adults
Sepsis, Acute Lung Injury(ALI)
Recruiting
Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise
Intensive Care Unit Acquired Weakness, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Polkey principal investigator
Royal Brompton Hospital and Imperial College
Susannah Bloch principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active muscle stimulation in people with Intensive Care Unit Acquired Paresis and Muscle Wasting, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle myostatin and FHL-1 (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2013.