Critical IllnessVALIDUMNCT04676464
VALIDation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient
An observational study of Critical Illness and Muscle Atrophy, run by Clinical Evaluation Research Unit at Kingston General Hospital.
Trial summary
The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Muscle Atrophy
- What is being tested?
- Ultra- sound
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Mar 2015
- 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: This study will enroll a broad heterogeneous patient population who will be admitted to the ICU for inpatient care. We are particularly interested in the cohort of patients with trauma but will enroll non-trauma patients who have CT scans as well to do some between group comparisons.
Who may be able to join
- Abdominal CT scan performed for clinical reasons within 24 hours before or 72 hours after admission
Who cannot join
- Patients under age 18 years
- Moribund patient with devastating injuries and not expected to survive
- Patients whose clinical condition precludes performing an ultrasound
- Pregnant women
- Prisoners
- Mentally-disabled individuals
About this study
Official title: VALIDation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient: The VALIDUM Study
The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons.
The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.
Read the detailed description
The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons.
The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.
This is a multi center, prospective, observation study across 5-6 intensive care units which will enroll 200 participants over a 12 month enrollment period followed by a 6 month period to complete data analysis.
This study will enroll a broad heterogeneous participant population who will be admitted to the ICU for inpatient care. We are particularly interested in the cohort of participant with trauma but will enroll non-trauma participants who have CT scans as well to do some between group comparisons. Participants enrolled to this study will be followed until they are discharged from the index hospital.
This is a prospective, observational study therefore no specific interventions will be associated with this study. The following information will be collected and recorded during ICU and hospital stay:
CT Images - All abdominal CT images conducted during the index hospitalization ordered for clinical purposes will be retrieved to precisely quantify muscle and adipose tissue mass.
Ultrasound - A portable ultrasound will be completed as soon as possible following the initial CT Scan, and again while a participant remains in hospital for each follow up CT of the abdomen for clinical reasons, where feasible, unless it is within a week of the previous CT scan.
Multiple Frequency Bioelectrical Impedance Analysis (MF-BIA) -MF-BIA is a non-invasive and simple-to-use method of measuring body composition and nutritional status in the clinical setting. MF-BIA measurements will be conducted every time an US measurement is done in the ICU following a CT Scan done for clinical reasons, unless it is within a week of the previous CT Scan and accompanying MF-BIA. After discharge from the ICU to the hospital, where feasible, MF BIA will be done every time an ultrasound is done following CT scans done for clinical reasons, unless it is within a week of the previous CT Scan and accompanying MF-BIA. MF-BIA will not be done on individuals with a pacemaker, Baseline patient demographics data and nutritional adequacy data will be collected.
- Conditions
- Critical Illness, Muscle Atrophy
- Being tested
- Ultra- sound
- Keywords
- computed tomography, muscle atrophy, muscle thickness, intensive care unit, ultrasound
- Medical subject headings
- Critical Illness, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra- soundDiagnostic test
Ultrasound assessment of quadricep muscle layer thickness QMLT within 72hrs of initial CT scan
| Study group | Role | What they receive |
|---|---|---|
| ultra- sound | ultra- sound assessment of their quadriceps muscle layer thickness (QMLT) Receives: Diagnostic Test: Ultra- sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of bedside US of QMLT
To evaluate the validity and reliability of bedside US by comparing measurements from US and to those estimates of lean body mass obtained from CT Scan of abdomen.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startDec 2013
- Primary completionJan 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daren K. Heyland, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676464
- Sponsor's protocol ID
- VALIDUM
- Acronym
- VALIDUM
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VALIDation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient: The VALIDUM Study
- ClinicalTrials.gov ID
- NCT04676464
- Acronym / sponsor ID
- VALIDUM / VALIDUM
- Conditions
- Critical Illness, Muscle Atrophy
- Keywords
- computed tomography, muscle atrophy, muscle thickness, intensive care unit, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General HospitalUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Dec 2020 (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.
The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons.
The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.
Detailed description
The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons.
The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.
This is a multi center, prospective, observation study across 5-6 intensive care units which will enroll 200 participants over a 12 month enrollment period followed by a 6 month period to complete data analysis.
This study will enroll a broad heterogeneous participant population who will be admitted to the ICU for inpatient care. We are particularly interested in the cohort of participant with trauma but will enroll non-trauma participants who have CT scans as well to do some between group comparisons. Participants enrolled to this study will be followed until they are discharged from the index hospital.
This is a prospective, observational study therefore no specific interventions will be associated with this study. The following information will be collected and recorded during ICU and hospital stay:
CT Images - All abdominal CT images conducted during the index hospitalization ordered for clinical purposes will be retrieved to precisely quantify muscle and adipose tissue mass.
Ultrasound - A portable ultrasound will be completed as soon as possible following the initial CT Scan, and again while a participant remains in hospital for each follow up CT of the abdomen for clinical reasons, where feasible, unless it is within a week of the previous CT scan.
Multiple Frequency Bioelectrical Impedance Analysis (MF-BIA) -MF-BIA is a non-invasive and simple-to-use method of measuring body composition and nutritional status in the clinical setting. MF-BIA measurements will be conducted every time an US measurement is done in the ICU following a CT Scan done for clinical reasons, unless it is within a week of the previous CT Scan and accompanying MF-BIA. After discharge from the ICU to the hospital, where feasible, MF BIA will be done every time an ultrasound is done following CT scans done for clinical reasons, unless it is within a week of the previous CT Scan and accompanying MF-BIA. MF-BIA will not be done on individuals with a pacemaker, Baseline patient demographics data and nutritional adequacy data will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultra- sound | – | Diagnostic Test: Ultra- soundultra- sound assessment of their quadriceps muscle layer thickness (QMLT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll a broad heterogeneous patient population who will be admitted to the ICU for inpatient care. We are particularly interested in the cohort of patients with trauma but will enroll non-trauma patients who have CT scans as well to do some between group comparisons.
Key inclusion criteria (1 listed)
- Abdominal CT scan performed for clinical reasons within 24 hours before or 72 hours after admission
Key exclusion criteria (6 listed)
- Patients under age 18 years
- Moribund patient with devastating injuries and not expected to survive
- Patients whose clinical condition precludes performing an ultrasound
- Pregnant women
- Prisoners
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 |
|---|---|---|
| Ultra- soundUltrasound assessment of quadricep muscle layer thickness QMLT within 72hrs of initial CT scan | Diagnostic test | ultra- sound |
Primary outcome
Validity of bedside US of QMLT
Time frame: 12 months
To evaluate the validity and reliability of bedside US by comparing measurements from US and to those estimates of lean body mass obtained from CT Scan of abdomen.
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 22 Dec 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Muscle Atrophy, run by Clinical Evaluation Research Unit at Kingston General Hospital.
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 6 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Validity of bedside US of QMLT (time frame: 12 months). 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 22 Dec 2020.