Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001196831
Ethics application status
Approved
Date submitted
19/07/2021
Date registered
8/09/2021
Date last updated
8/09/2021
Date data sharing statement initially provided
8/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
NeuroMuscle
Association between acute muscle wasting and functional deficits following severe traumatic brain injury: observational cohort study
Scientific title
NeuroMuscle
Association between acute muscle wasting and functional deficits following severe traumatic brain injury: observational cohort study
Secondary ID [1] 304822 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 322891 0
Acute muscle loss (Secondary sarcopenia) 322892 0
Functional deficits 322893 0
Catabolic state 322894 0
Intracerebral haemorrhage 323245 0
Epidural haemorrhage 323246 0
Subarachnoid haemorrhage 323247 0
Subdural haemorrhage 323248 0
Diffuse axonal injury
323249 0
Intraparenchymal Haemorrhage 323250 0
Condition category
Condition code
Neurological 320471 320471 0 0
Other neurological disorders
Musculoskeletal 320472 320472 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 320473 320473 0 0
Other metabolic disorders
Injuries and Accidents 320818 320818 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To quantify acute phase muscle wasting in critically ill patients post severe traumatic brain injury and determine associations with functional outcomes and nutrition provision. From day 1-2 of intensive care unit (ICU) admission up to 28 days from initial scan.
What is involved for participants;
a) ultrasound of rectus femoris and vastus intermedius muscles, with each scan taking approximately 15 minutes; the ultrasound assessments will be performed by study researchers who are either physiotherapists, an intensive care specialist, or sonographers.
The ultrasound assessments will be performed at 48 hours from intensive care admission, and 7, 14, 21, and 28 days post-ICU admission. The total duration of observation will be approximately 75 minutes (5 assessment timepoints that each will take approximately 15 minutes to complete).
b) Three tests of physical functioning including:
1. 10 metre walk test (day 28 or acute hospital discharge if prior to day 28).
2. Timed up and go (day 28 or acute hospital discharge if prior to day 28).
3. Handgrip strength (day 28 or acute hospital discharge if prior to day 28).
Each physical function test will take approximately 5 minutes to complete. These physical function tests will be performed by study researchers who are also physiotherapists. These physical assessments will only be performed once at day 28 or at acute hospital discharge if prior to day 28. The total duration of the physical assessments will be approximately 15 minutes.
c) Follow-up phone call or interview 6-months following ICU admission. If the participant has been discharged from the hospital then the interview will be conducted over the telephone. If the participant remains in hospital the interview will be conducted in person. The follow-up will take approximately 15 minutes and the following assessments will be conducted:
1. Days alive and out of hospital,
2. Health related quality of life (EQ5D-5L),
3. Return to work (if working prior to admission),
4. Independence with ADLs (Barthel Index).
The follow-up interviews / phone calls will be made by study researchers who are also physiotherapists.

Demographic data and nutrition information will also be collected from medical records. Participants will not be required to perform or received any additional tests to ascertain this information. Following person responsible consent the following information will be collected from the patients medical records:
Admission injury and illness severity scores (Acute Physiology And Chronic Health Evaluation III (APACHE III), admission Sequential Organ Failure Assessment (SOFA), modified Nutrition Risk Calculation (mNUTRIC) and Glasgow Coma Scale Scores (GCS)), duration of mechanical ventilation (hours), incidence of delirium in ICU (delirium free days) (Cognitive Assessment Measure (CAM ICU)), weight, height, body mass index, adjusted weight, diabetes on admission, nutrition received (name and volume of parental nutrition feed), volume of feed during ICU admission, volume of discarded gastric residual volumes, propofol received, type and volume of carbohydrate infusion, urea level, creatine level, blood glucose levels and units of insulin.
Length of stay – ICU, acute hospital, rehabilitation.
Acute hospital discharge destination (home, rehab, other hospital, died).

Following the provision of consent the person responsible for the participant will be asked a few questions (less than 5 minutes duration) to enable a pre-admission Clinical Frailty Score, and SARC-F questionnaire to be completed. This will assist to quantify the participants pre-admission level of function.
Intervention code [1] 321197 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328307 0
Bilateral rectus femoris cross sectional area muscle size assessed by ultrasound sonography
Timepoint [1] 328307 0
Baseline, and 7 (+/-1 day), 14 (+/-1 day) (primary endpoint), 21(+/-1 day), and 28 (+/-1 day) days post-ICU admission or until acute hospital discharge (whichever occurs earlier).
Secondary outcome [1] 398505 0
10 metre walk test (physical assessment)
Timepoint [1] 398505 0
Day 28 or acute hospital discharge if prior to day 28
Secondary outcome [2] 399697 0
Bilateral rectus femoris thickness muscle size loss (assessed by ultrasound sonography)
Timepoint [2] 399697 0
Baseline, and 7 (+/-1 day), 14 (+/-1 day) (primary endpoint), 21(+/-1 day), and 28 (+/-1 day) days post-ICU admission or until acute hospital discharge (whichever occurs earlier).
Secondary outcome [3] 399698 0
Timed up and go (physical assessment)
Timepoint [3] 399698 0
Day 28 or acute hospital discharge if prior to day 28.
Secondary outcome [4] 399699 0
Bilateral Handgrip strength (physical assessment) using a handheld Jamar digital dynamometer
Timepoint [4] 399699 0
Day 28 or acute hospital discharge if prior to day 28.
Secondary outcome [5] 399700 0
ICU Mobility Scale score - Highest level of function in intensive care (information obtained from medical records).
Timepoint [5] 399700 0
ICU discharge
Secondary outcome [6] 399701 0
Barthel Index (information obtained from medical records).
Timepoint [6] 399701 0
Acute hospital discharge
Secondary outcome [7] 399702 0
Time to achieve functional milestones – sitting on the edge of the bed (information obtained from medical records).
Timepoint [7] 399702 0
Index hospital admission discharge
Secondary outcome [8] 399703 0
Time to achieve functional milestones – sit out of bed (information obtained from medical records).
Timepoint [8] 399703 0
Index hospital admission discharge
Secondary outcome [9] 399704 0
Time to achieve functional milestones – standing (information obtained from medical records).
Timepoint [9] 399704 0
Index hospital admission discharge
Secondary outcome [10] 399705 0
Time to achieve functional milestones – mobilisation with assistance (information obtained from medical records).
Timepoint [10] 399705 0
Index hospital admission discharge
Secondary outcome [11] 399706 0
Time to achieve functional milestones – independent mobility (information obtained from medical records).
Timepoint [11] 399706 0
Index hospital admission discharge
Secondary outcome [12] 399707 0
Days alive and out of hospital (information obtained from medical records and participant follow-up interview at 6 months).
Timepoint [12] 399707 0
6 months following intensive care unit admission.
Secondary outcome [13] 399708 0
Health related quality of life (EQ5D-5L), (assessed during follow-up interview)
Timepoint [13] 399708 0
6 months following intensive care unit admission.
Secondary outcome [14] 399709 0
Return to work (if working prior to admission) assessed using a study-specific questionnaire assessed during follow-up interview.
Timepoint [14] 399709 0
6 months following intensive care unit admission.
Secondary outcome [15] 399710 0
Independence with activities of daily living (Barthel Index).
Timepoint [15] 399710 0
6 months following intensive care unit admission.
Secondary outcome [16] 399716 0
Nutrition received (name and volume of parental nutrition feed), (information obtained from medical records).
Timepoint [16] 399716 0
ICU discharge
Secondary outcome [17] 399718 0
Volume of discarded gastric residual volumes (information obtained from medical records).
Timepoint [17] 399718 0
ICU discharge
Secondary outcome [18] 399719 0
Propofol received (information obtained from medical records).
Timepoint [18] 399719 0
ICU discharge
Secondary outcome [19] 399720 0
Type and volume of carbohydrate infusion (information obtained from medical records).
Timepoint [19] 399720 0
ICU discharge
Secondary outcome [20] 399721 0
Blood analysis to determine urea level, creatine level, blood glucose levels (information obtained from medical records).
Timepoint [20] 399721 0
ICU discharge
Secondary outcome [21] 399722 0
Length of stay ICU, information obtained from medical records.
Timepoint [21] 399722 0
Index hospital admission at ICU discharge
Secondary outcome [22] 400620 0
Length of stay in acute hospital, information obtained from medical records.
Timepoint [22] 400620 0
Index hospital admission at acute hospital discharge
Secondary outcome [23] 400621 0
Length of stay in inpatient rehabilitation, information obtained from medical records.
Timepoint [23] 400621 0
Index hospital admission Inpatient rehabilitation discharge
Secondary outcome [24] 400622 0
Acute hospital discharge destination (home, rehab, other hospital, died). Information obtained from medical records.
Timepoint [24] 400622 0
At discharge from index hospital admission
Secondary outcome [25] 400623 0
Days alive and out of hospital over 6 months.
Calculated as 180 days minus calendar days as hospital inpatient over 6 months from initial index hospital admission, including readmissions to hospital, information obtained from medical records.
Timepoint [25] 400623 0
6 months (180 days) following initial index hospital admission

Eligibility
Key inclusion criteria
1. Able to have a family member or next of kin consent on the patient’s behalf.
2. Traumatic brain injury (TBI) requiring an intensive care unit admission.
Injuries may include:
Intracerebral haemorrhage
Epidural haemorrhage
Subdural haemorrhage
Subarachnoid haemorrhage
Intraparenchymal Haemorrhage
Diffuse axonal injury
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Dire prognosis (i.e. unlikely to survive the current admission)
2. Spinal cord injury
3. Acute injuries that prohibit ultrasound assessment of thigh musculature i.e. lacerations or open wounds.
4. People who are incarcerated.
5. Women who are pregnant
6. Participants with significant pre-existing cognitive impairment, intellectual disability or mental illness.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As this is an observational study descriptive statistics will be used to describe the clinical characteristics of the cohort and the participants outcomes. An exploratory analysis will be conducted to examine the:
1. Association between acute muscle wasting and functional decline following a severe traumatic brain injury.
2. Association between nutritional intake in intensive care (protein and energy) and acute muscle wasting at intensive care unit discharge in patients with a severe traumatic brain injury.
3. Association between acute muscle wasting and blood glucose levels and/ or insulin requirements following a severe traumatic brain injury.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2021
Actual
Date of last participant enrolment
Anticipated
6/06/2022
Actual
Date of last data collection
Anticipated
6/12/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20005 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 34714 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 309195 0
Government body
Name [1] 309195 0
Metro South Health
Country [1] 309195 0
Australia
Primary sponsor type
Government body
Name
Metro South Health
Address
Princess Alexandra Hospital
Ipswich Road
Woolloongabba,
Queensland, 4102
Country
Australia
Secondary sponsor category [1] 310155 0
None
Name [1] 310155 0
Address [1] 310155 0
Country [1] 310155 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309049 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 309049 0
Princess Alexandra Hospital
Ipswich Road
Woolloongabba,
QLD 4102
Ethics committee country [1] 309049 0
Australia
Date submitted for ethics approval [1] 309049 0
Approval date [1] 309049 0
01/07/2021
Ethics approval number [1] 309049 0
HREC2021/QMS/74628

Summary
Brief summary
This study aims to observe acute muscle loss in patients with an acute severe traumatic brain injury over the first 28 days. To date acute muscle loss following the first 7 days following traumatic brain injury has not been reported. This study will assist to determine if there is an association between acute muscle wasting and functional impairments following a severe traumatic brain injury. The study will also determine if enteral or parenteral nutritional intake whilst admitted to intensive care (energy and protein) is associated with acute muscle wasting.
This observational study is expected to lay the foundation for future interventional studies to assess the effect of exercise or nutrition (or a combination of both) on muscle loss and functional recovery following a severe traumatic brain injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112786 0
Dr Marc Nickels
Address 112786 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba,
QLD 4102
Country 112786 0
Australia
Phone 112786 0
+61731762401
Fax 112786 0
Email 112786 0
[email protected]
Contact person for public queries
Name 112787 0
Dr Marc Nickels
Address 112787 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba,
QLD 4102
Country 112787 0
Australia
Phone 112787 0
+61731762401
Fax 112787 0
Email 112787 0
[email protected]
Contact person for scientific queries
Name 112788 0
Dr Marc Nickels
Address 112788 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba,
QLD 4102
Country 112788 0
Australia
Phone 112788 0
+61731762401
Fax 112788 0
Email 112788 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified research data of all research data collected during the study will be stored on an appropriate research data repository.
When will data be available (start and end dates)?
Available for 5 years after publication of main results.
Available to whom?
Other researchers for other approved research studies.
Available for what types of analyses?
Type of analyses will be dependent upon the researchers research question, proposed analysis and ethical approval to access the research data.
How or where can data be obtained?
The appropriate research data repository will be determined at the completion of the study and the details of the data repository will be published with the studies primary peer reviewed publication.
Please email the Principal Investigator: [email protected] with any queries regarding accessing the data.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.