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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03019913




Registration number
NCT03019913
Ethics application status
Date submitted
11/01/2017
Date registered
13/01/2017

Titles & IDs
Public title
Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients
Scientific title
Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study
Secondary ID [1] 0 0
523/16
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Observational cohort

Other interventions: Observational cohort
Evaluation of bedside methods to measure muscularity in critically ill patients
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean skeletal muscle mass measured by CT scan analysis at L3 area (cm2)
Timepoint [1] 0 0
CT performed for clinical reasons =24 hours before or =72 hours after ICU admission
Primary outcome [2] 0 0
Mean skeletal muscle mass measured by ultrasound (muscle thickness at each site, cm and rectus femoris CSA, cm2)
Timepoint [2] 0 0
<48 hours after CT scan containing L3 area
Secondary outcome [1] 0 0
Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy
Timepoint [1] 0 0
<48 hours after CT scan containing L3 area
Secondary outcome [2] 0 0
Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)
Timepoint [2] 0 0
<48 hours after CT scan containing L3 area
Secondary outcome [3] 0 0
Mid arm muscle circumference (cm)
Timepoint [3] 0 0
<48 hours after CT scan containing L3 area
Secondary outcome [4] 0 0
Mean skeletal muscle mass measured by CT scan analysis at femoral area (cm2)
Timepoint [4] 0 0
CT performed for clinical reasons =24 hours before or =72 hours after ICU admission
Secondary outcome [5] 0 0
Measured resting energy expenditure (kilojoules)
Timepoint [5] 0 0
<48 hours after CT scan containing L3 area
Secondary outcome [6] 0 0
Intramuscular, subcutaneous and visceral adipose tissue CSA at L3 area (cm2)
Timepoint [6] 0 0
CT performed for clinical reasons =24 hours before or =72 hours after ICU admission

Eligibility
Key inclusion criteria
* Have had a CT scan of the L3 vertebra performed for clinical reasons =24 hours before or =72 hours after ICU admission
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* CT scan performed >48hrs ago
* Death is imminent or deemed highly likely in the next 96 hours
* Are known to be pregnant
* Treating clinician does not believe the study to be in the best interest of the patient
* It is not possible to image two or more muscle groups via ultrasound (i.e. due to trauma, burns, wounds)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2019
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
La Trobe University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kate Lambell, MNutrDiet
Address 0 0
La Trobe University and Alfred Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03019913