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Trial registered on ANZCTR
Registration number
ACTRN12624001007527
Ethics application status
Approved
Date submitted
25/07/2024
Date registered
20/08/2024
Date last updated
20/08/2024
Date data sharing statement initially provided
20/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of supplemental ketone drinks in patients with brain injury on improve long term outcomes: A feasibility study
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Scientific title
THE KIND STUDY: A pilot randomised controlled trial assessing the feasibility of ketone administration in adults with neurological damage
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Secondary ID [1]
312622
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
subarachnoid haemorrhage
334563
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brain injury
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intracerebral haemorrhage
334565
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Condition category
Condition code
Neurological
331167
331167
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0
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Other neurological disorders
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Stroke
331168
331168
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0
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Haemorrhagic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Trial participants randomised to ketone ester supplementation (R-1,3-Butanediol, 0.29grams/ml) will have this preparation administered via nasogastric tube within eight hours of ICU admission.
Dose: 40g bolus of ketone esters followed by 10g/hr NG infusion of KE for 12 hours and then cease
Adherence to the intervention will be monitored by administration documented in paper medical record and drug chart, as well as by study investigators.
Product: The KE supplement is a clear, colourless liquid solution that comes packaged in plastic bottles. It is manufactured by Health Via Modern Nutrition Inc, USA under the brand name, Ketone-IQ. It can be administered via syringe or an enteral feeding set down the participants nasogastric tube by ICU nursing or medical staff.
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Intervention code [1]
329138
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Treatment: Other
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Comparator / control treatment
Trial participants randomised to placebo will have this administered via nasogastric tube within eight hours of ICU admission (ideally within 4 hours of hospital presentation). The placebo substance will be sterile water prepared in similar bottles by the same company.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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The primary outcome will be study feasibility. The study will be deemed feasible if all of the following criteria are met:
1. Less than or equal to 50% of patients (or their proxies) refuse to participate on the basis of concerns over ketone administration
2. Greater than or equal to 80% of patients randomised to ketone ester supplementation receive them within the first eight hours of ICU admission
Data gathered for assessment of these measures will be documented on a secure server on a computer within the research department of the ICU, after transcription from the study report form. These will be recorded on RedCap software.
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Timepoint [1]
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Upon conclusion of study
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Secondary outcome [1]
437939
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Percentage of patients achieving ketosis in blood (ketones > 2)
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Assessment method [1]
437939
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Blood ketone level
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Timepoint [1]
437939
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Ketone levels will be measured at Baseline, 4 and 8 hours post-ICU admission. Overall assessment of percentage of patients receiving ketosis will occur upon conclusion of the study.
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Secondary outcome [2]
437940
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Description of CSF (cerebrospinal fluid) lactate levels (note this will only be performed if an extra-ventricular drain (EVD) is in situ so patients will not be exposed to additional invasive tests as part of this study
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Assessment method [2]
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CSF biochemistry (via laboratory)
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Timepoint [2]
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Baseline, 4 and 8 hours post-ICU admission
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Secondary outcome [3]
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Level of serum S100B (brain injury marker)
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Assessment method [3]
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Serum (blood) biochemistry -- laboratory test
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Timepoint [3]
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Baseline and 24 hours post-ICU admission
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Secondary outcome [4]
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Adverse side effects (acidosis, dysglycemia, intracranial hypertension, reduced cerebral perfusion pressure)
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Assessment method [4]
437942
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Nursing recording of standard patient observations on an hourly basis on paper ICU bedside chart
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Timepoint [4]
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Hourly from baseline to 24 hours post ICU admission
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Secondary outcome [5]
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Modified Rankin scale at 3 months following discharge -- assesses the level of disability and functional recovery following neurological injury
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Assessment method [5]
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Modified Rankin Scale (functional outcome score validated for neurological injury) performed by trained research data scientists, research nurses, and study investigators via Telehealth
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Timepoint [5]
437943
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Baseline and 3 months post ICU admission
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Secondary outcome [6]
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Description of CSF (cerebrospinal fluid) ketone levels (note this will only be performed if an extra-ventricular drain (EVD) is in situ so patients will not be exposed to additional invasive tests as part of this study
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Assessment method [6]
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Biochemical via laboratory
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Timepoint [6]
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At 4 and 8 hours post ICU admission
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Eligibility
Key inclusion criteria
Any patient, intubated and mechanically ventilated with a nasogastric tube, within 8 hours of admission who is anticipated to survive at least 72 hours with the following:
1. Patients with subarachnoid haemorrhage with an admission Glasgow Coma Scale (GCS) less than or equal to 8
2. Patients admitted following out of hospital cardiac arrest who are intubated with a GCS less than or equal to 8
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Age < 18 years old
2. Pregnant
3. Suffering from Acute or Chronic liver disease
4. Type 1 diabetes mellitus
5. Treating clinician determines that the administration of ketone esters is inappropriate for the patient
6. Base of skull fracture precluding insertion of nasogastric tube (NGT)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be maintained using sequential opaque sealed envelopes stored in the ICU.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur in a 1:1 ratio and occur as soon as possible following admission to the Intensive Care Unit. Randomisation will be derived from a computer-generated random number sequence.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/08/2024
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Actual
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Date of last participant enrolment
Anticipated
2/06/2025
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Actual
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Date of last data collection
Anticipated
8/09/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
317055
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Government body
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Name [1]
317055
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North Metropolitan Health Western Australia
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Address [1]
317055
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Country [1]
317055
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Australia
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Funding source category [2]
317056
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Charities/Societies/Foundations
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Name [2]
317056
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Charlies Bright Ideas Foundation
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Address [2]
317056
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Country [2]
317056
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Australia
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Funding source category [3]
317057
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Charities/Societies/Foundations
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Name [3]
317057
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Intensive Care Foundation
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Address [3]
317057
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Country [3]
317057
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Australia
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Primary sponsor type
Hospital
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Name
Sir Charles Gairdner Hospital, Western Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
319304
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None
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Name [1]
319304
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Address [1]
319304
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Country [1]
319304
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315806
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Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
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Ethics committee address [1]
315806
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https://www.scgh.health.wa.gov.au/Research/Department-of-Research/My-Project/HREC
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Ethics committee country [1]
315806
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Australia
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Date submitted for ethics approval [1]
315806
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15/11/2023
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Approval date [1]
315806
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21/03/2024
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Ethics approval number [1]
315806
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Summary
Brief summary
The aim of this study is to determine the feasibility of giving ketone bodies in the form of dietary supplementation to patients with acute neurological injury admitted to ICU in order to improve neurological outcomes. This study will use be a randomised controlled trial, a well known study design that eliminates study biases that can confound findings as much as possible in order to determine the true utility of the use of ketones in brain injury. Patients who are in a coma with an acute brain injury, admitted to ICU, will be eligible to participate in this trial. Participants will be randomised (like the toss of a coin) to routine administration of ketone bodies via a feeding tube on admission and standard care, or placebo and standard care alone. Ketone body supplementation is currently not available for ICU patients and will only be available within this trial. Determining the feasibility of giving ketone bodies to patients with acute brain injury admitted to ICU is the first important step in a program of research that ultimately aims to test the efficacy of using ketone bodies in this group of patients to improve neurological outcomes and reduce disability.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Vanessa Carnegie
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Address
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Intensive Care Unit, Level 4, G Block, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands Western Australia 6009
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Country
135862
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Australia
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Phone
135862
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+61 447526181
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Fax
135862
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Email
135862
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[email protected]
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Contact person for public queries
Name
135863
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Vanessa Carnegie
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Address
135863
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Intensive Care Unit, Level 4, G Block, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands Western Australi 6009
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Country
135863
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Australia
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Phone
135863
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+61 447526181
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Fax
135863
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Email
135863
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[email protected]
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Contact person for scientific queries
Name
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Vanessa Carnegie
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Address
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Intensive Care Unit, Level 4, G Block, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands Western Australia 6009
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Country
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Australia
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Phone
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+61 447526181
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Fax
135864
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Email
135864
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24032
Study protocol
388201-(Uploaded-12-08-2024-23-44-21)-final ANZCTR manuscript.pdf
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Informed consent form
388201-(Uploaded-25-07-2024-14-31-50)-KindMaster PICF and information sheet PR- RDM V 1.5 clean_ (1).docx
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Informed consent form
388201-(Uploaded-25-07-2024-14-32-03)-KIND_Adult own consent (to continue) v1.3 12.07.2022.docx
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.
Download to PDF