Muscle LossNCT03184623
Muscle Mass and Body Composition
An observational study of Muscle Loss, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
ICUacquired weakness is a common complication of critical illness, particularly in patients receiving mechanical ventilation and/or suffering from conditions leading to the systemic inflammatory response syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Loss
- What is being tested?
- muscle mass measurement
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Jun 2017to 5 Sep 2017
- Phase
- Observational
- 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
Study population: patients admitted to the ICU with an expected lenght of stay > 48 hours
Who may be able to join
- all acute admitted patients in ICU
Who cannot join
- age < 18
- stay on ICU < 48 hours
- use of corticosteroids
- neurological diseases
- acute kidney injure / nead of CVVH
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Course of Changes in Muscle Mass and Body Composition During ICU Admission
ICUacquired weakness is a common complication of critical illness, particularly in patients receiving mechanical ventilation and/or suffering from conditions leading to the systemic inflammatory response syndrome.
Read the detailed description
The weakness and disability that result from these neuromuscular disorders can dominate the lont-term course and impede recovery.
In this observational study we try to measure muscle mass and body composition by echocardiography and BIVA at admission and on day 2, 5
- Conditions
- Muscle Loss
- Being tested
- muscle mass measurement
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle mass measurementOther
measurement of muscle mass by echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
change in muscle mass measurements during ICU stay
measurement by echography
Measured: baseline, day 2 and day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start9 Jun 2017
- Primary completion5 Sep 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matty Koopmans, Frisius Medisch Centrum
- Investigators
- Matty Koopmans, MSc, Principal investigator, MCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184623
- Sponsor's protocol ID
- nWMO 205
- Status last verified
- Sep 2017
- First submitted
- 9 Jun 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course of Changes in Muscle Mass and Body Composition During ICU Admission
- ClinicalTrials.gov ID
- NCT03184623
- Acronym / sponsor ID
- nWMO 205
- Conditions
- Muscle Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 12 Jun 2017 (actual)
- 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.
ICUacquired weakness is a common complication of critical illness, particularly in patients receiving mechanical ventilation and/or suffering from conditions leading to the systemic inflammatory response syndrome.
Detailed description
The weakness and disability that result from these neuromuscular disorders can dominate the lont-term course and impede recovery.
In this observational study we try to measure muscle mass and body composition by echocardiography and BIVA at admission and on day 2, 5
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to the ICU with an expected lenght of stay > 48 hours
Key inclusion criteria (1 listed)
- all acute admitted patients in ICU
Key exclusion criteria (5 listed)
- age < 18
- stay on ICU < 48 hours
- use of corticosteroids
- neurological diseases
- acute kidney injure / nead of CVVH
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 |
|---|---|---|
| muscle mass measurementmeasurement of muscle mass by echocardiography | Other | – |
Primary outcome
change in muscle mass measurements during ICU stay
Time frame: baseline, day 2 and day 5
measurement by echography
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 8 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Matty Koopmans, MSc principal investigator
MCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Loss, run by Frisius Medisch Centrum at 1 site in Netherlands.
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 5 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 8 Sep 2017. 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 Netherlands. 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 mass measurements during ICU stay (time frame: baseline, day 2 and day 5). 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 8 Sep 2017; AzTrials last refreshed its copy on 30 Oct 2026.