Trial Review

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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
Scientific title
THE KIND STUDY: A pilot randomised controlled trial assessing the feasibility of ketone administration in adults with neurological damage
Secondary ID [1] 312622 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subarachnoid haemorrhage 334563 0
brain injury 334564 0
intracerebral haemorrhage 334565 0
Condition category
Condition code
Neurological 331167 331167 0 0
Other neurological disorders
Stroke 331168 331168 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329138 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 338931 0
Feasibility
Timepoint [1] 338931 0
Upon conclusion of study
Secondary outcome [1] 437939 0
Percentage of patients achieving ketosis in blood (ketones > 2)
Timepoint [1] 437939 0
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.
Secondary outcome [2] 437940 0
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
Timepoint [2] 437940 0
Baseline, 4 and 8 hours post-ICU admission
Secondary outcome [3] 437941 0
Level of serum S100B (brain injury marker)
Timepoint [3] 437941 0
Baseline and 24 hours post-ICU admission
Secondary outcome [4] 437942 0
Adverse side effects (acidosis, dysglycemia, intracranial hypertension, reduced cerebral perfusion pressure)
Timepoint [4] 437942 0
Hourly from baseline to 24 hours post ICU admission
Secondary outcome [5] 437943 0
Modified Rankin scale at 3 months following discharge -- assesses the level of disability and functional recovery following neurological injury
Timepoint [5] 437943 0
Baseline and 3 months post ICU admission
Secondary outcome [6] 438538 0
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
Timepoint [6] 438538 0
At 4 and 8 hours post ICU admission

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2024
Actual
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
8/09/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317055 0
Government body
Name [1] 317055 0
North Metropolitan Health Western Australia
Country [1] 317055 0
Australia
Funding source category [2] 317056 0
Charities/Societies/Foundations
Name [2] 317056 0
Charlies Bright Ideas Foundation
Country [2] 317056 0
Australia
Funding source category [3] 317057 0
Charities/Societies/Foundations
Name [3] 317057 0
Intensive Care Foundation
Country [3] 317057 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital, Western Australia
Address
Country
Australia
Secondary sponsor category [1] 319304 0
None
Name [1] 319304 0
Address [1] 319304 0
Country [1] 319304 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315806 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 315806 0
https://www.scgh.health.wa.gov.au/Research/Department-of-Research/My-Project/HREC
Ethics committee country [1] 315806 0
Australia
Date submitted for ethics approval [1] 315806 0
15/11/2023
Approval date [1] 315806 0
21/03/2024
Ethics approval number [1] 315806 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135862 0
Dr Vanessa Carnegie
Address 135862 0
Intensive Care Unit, Level 4, G Block, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands Western Australia 6009
Country 135862 0
Australia
Phone 135862 0
+61 447526181
Fax 135862 0
Email 135862 0
[email protected]
Contact person for public queries
Name 135863 0
Vanessa Carnegie
Address 135863 0
Intensive Care Unit, Level 4, G Block, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands Western Australi 6009
Country 135863 0
Australia
Phone 135863 0
+61 447526181
Fax 135863 0
Email 135863 0
[email protected]
Contact person for scientific queries
Name 135864 0
Vanessa Carnegie
Address 135864 0
Intensive Care Unit, Level 4, G Block, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands Western Australia 6009
Country 135864 0
Australia
Phone 135864 0
+61 447526181
Fax 135864 0
Email 135864 0
[email protected]

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


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.