- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184623
Muscle Mass and Body Composition
September 5, 2017 updated by: Matty Koopmans, Medical Centre Leeuwarden
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
23
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leeuwarden, Netherlands, 8934AD
- Medical Center Leeuwarden
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients admitted to the ICU with an expected lenght of stay > 48 hours
Description
Inclusion Criteria:
- all acute admitted patients in ICU
Exclusion Criteria:
- age < 18
- stay on ICU < 48 hours
- use of corticosteroids
- neurological diseases
- acute kidney injure / nead of CVVH
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in muscle mass measurements during ICU stay
Time Frame: baseline, day 2 and day 5
|
measurement by echography
|
baseline, day 2 and day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matty Koopmans, MSc, MCL
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2017
Primary Completion (Actual)
September 5, 2017
Study Completion (Actual)
September 5, 2017
Study Registration Dates
First Submitted
June 9, 2017
First Submitted That Met QC Criteria
June 9, 2017
First Posted (Actual)
June 12, 2017
Study Record Updates
Last Update Posted (Actual)
September 8, 2017
Last Update Submitted That Met QC Criteria
September 5, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- nWMO 205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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