Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001236381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
27/08/2026
Date registered
Help: Date registered
12/10/2026
Date last updated
Help: Date last updated
12/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
12/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Is it feasible to administer an enteral ketone supplement to critically ill patients and raise their blood ketone levels? (KICC feasibility trial)
Scientific title
Is it feasible to administer an enteral ketone supplement to critically ill patients and raise their blood ketone levels? (KICC feasibility trial)
Additional trial identifiers [1] 318293 0
Nil
Universal Trial Number (UTN)
Trial acronym
KICC
Related trial records

Health condition
Health condition(s) studied:
Critical illness 343423 0
Condition category
Condition code
Blood 339501 339501 0 0
Haematological diseases
Cardiovascular 339502 339502 0 0
Diseases of the vasculature and circulation including the lymphatic system
Infection 339503 339503 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 339504 339504 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 339505 339505 0 0
Other injuries and accidents
Metabolic and Endocrine 339506 339506 0 0
Diabetes
Neurological 339507 339507 0 0
Other neurological disorders
Oral and Gastrointestinal 339508 339508 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Renal and Urogenital 339509 339509 0 0
Kidney disease
Respiratory 339510 339510 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is a liquid form of a ketone ester (D-ß-hydroxybutyrate-D-1,3-butanediol) that is classed as a nutritional supplement. It is colourless and odourless.
The ketone ester will be administered to participants at a slow continuous rate via an enteral feeding tube after an initial bolus dose is given. Doses are calculated based on a participant’s weight, therefore, doses could range from approximately 90 ml – 300 ml per day. Recruited participants will receive the intervention until their feeding tube is removed, they are discharged from the ICU, 7 days from randomisation has elapsed, or their death.
An accurate formula for dosing will be determining during the trial to find the correct weight-based formula for participants, which may vary administration doses during the trial. Serum ketone concentrations will be measured every 6 hours and analysed by unblinded study members to ensure the correct dose of the ketone ester is administered. Any changes to dosing will be determined by a trial safety committee. The intervention is given in conjunction with standard of care; it does not impact nutrition or other therapies. Details of the intervention dosing and infusion rates will be provided on a publicly accessible website (including but not limited to the ANZCTR registry) once the study has been completed. Details of intervention ingredients will be provided on the ANZCTR registry following completion of statistical analyses.
Intervention code [1] 335193 0
Treatment: Other
Description of the comparator or control
The comparator (placebo) is water. This will be dosed and delivered in exactly the same fashion as the intervention.
The placebo will be administered to participants at a slow continuous rate via an entera feeding tube after an initial bolus dose is given. Doses are calculated based on a participant’s weight, therefore, doses could range from approximately 90 ml – 300 ml per day. Recruited participants will receive the placebo until their feeding tube is removed, they are discharged from the ICU, 7 days from randomisation has elapsed, or their death.
Serum ketone concentrations will be measured every 6 hours and analysed by unblinded study members. There will be no other special monitoring of strategies of those patients recruited into the placebo arm.
Control group
Placebo

Outcomes
Primary outcome [1] 346693 0
Recruitment rate, with a feasibility target of two or more patients per month of recruitment
Timepoint [1] 346693 0
24 months post-study commencement
Primary outcome [2] 346892 0
Adherence to protocol, defined as the proportion of prescribed intervention administered in the intervention group with an administration target of 80% or greater.
Timepoint [2] 346892 0
80% or greater of prescribed intervention or placebo administered to a participant during their recruitment into the trial as assessed at the end of the individual’s recruitment period
Primary outcome [3] 346894 0
A composite outcome of adherence to protocol, defined as time in range, defined as blood D-ßHB concentration between 2.0 and 5.0 mM in the intervention group, with a target of 70% of time or greater within target range.
Timepoint [3] 346894 0
Every 6 hours for up to 7 days post-commencement of infusion
Secondary outcome [1] 468020 0
Consent rates; defined as the number of participants randomised as a proportion of the total number of medical treatment decision makers (MTDMs) that were approached for consent and had a discussion with a study investigator.
Timepoint [1] 468020 0
During the trial's screening and recruitment period, estimated to be up to 24 months
Secondary outcome [2] 468024 0
Incidence of gastrointestinal adverse events defined as diarrhoea as per WHO guidelines, enteral feed intolerance as per local guidelines, and participant reported abdominal discomfort.
Timepoint [2] 468024 0
During a participant's recruited period into the trial.

Eligibility
Key inclusion criteria
1. Adults over 18 years old.

2. Admitted to the Intensive Care Unit at any phase of their illness.

3. A patient who is mechanically ventilated and predicted to be mechanically ventilated until the end of the next calendar day.

4. A patient who has an enteral feeding tube in-situ.

5. A patient currently receiving, or is suitable to receive, enteral nutrition.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Pregnant or lactating patients.

2. Patients with an absolute body weight of more than or equal to 150 kg.

3. Patients with severe diabetic, starvation or alcohol related ketoacidosis defined as a pH < 7.2 and blood ketone level > 2 mM.

4. Patients who have been mechanically ventilated in a trial site ICU for more than 120 hours.

5. Patients with known genetic disorders of metabolism.

6. Treating clinician believes that a ketogenic diet is required.

7. Treating clinician believes a specific liquid nutrient is required for this patient.

8. Treating clinician does not believe the patient should be included for any reason

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The intervention is colourless, odourless, and has viscosity similar to water. Therefore, both intervention and placebo will be stored in mildly opaque nutritional delivery devices (bottles) and will be indistinguishable from one another. The bottles will be sealed and identifiable if they have been tampered with prior to selection for administration. The intervention and placebo will always be handled by blinded operators. Selection of a bottle will be based on central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Web-based random allocation using REDCap.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 30087 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 46482 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 322850 0
Charities/Societies/Foundations
Name [1] 322850 0
Australian and New Zealand Intensive Care Society
Country [1] 322850 0
Australia
Primary sponsor type
University
Name
Univeristy of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 325784 0
None
Name [1] 325784 0
Address [1] 325784 0
Country [1] 325784 0
Other collaborator category [1] 284067 0
Hospital
Name [1] 284067 0
Royal Melbourne Hospital
Address [1] 284067 0
Country [1] 284067 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321286 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 321286 0
Ethics committee country [1] 321286 0
Australia
Date submitted for ethics approval [1] 321286 0
24/04/2026
Approval date [1] 321286 0
21/05/2026
Ethics approval number [1] 321286 0

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

Contacts
Principal investigator
Name 153254 0
Dr Mohamed Kamal
Address 153254 0
Intensive Care Unit - Royal Melbourne Hospital, 300 Grattan Street, Parkville, Melbourne, Victoria, 3050
Country 153254 0
Australia
Phone 153254 0
+61 393427000
Fax 153254 0
Email 153254 0
[email protected]
Contact person for public queries
Name 153255 0
Mohamed Kamal
Address 153255 0
Intensive Care Unit - Royal Melbourne Hospital, 300 Grattan Street, Parkville, Melbourne, Victoria, 3050
Country 153255 0
Australia
Phone 153255 0
+61 393427000
Fax 153255 0
Email 153255 0
[email protected]
Contact person for scientific queries
Name 153256 0
Mohamed Kamal
Address 153256 0
Intensive Care Unit - Royal Melbourne Hospital, 300 Grattan Street, Parkville, Melbourne, Victoria, 3050
Country 153256 0
Australia
Phone 153256 0
+61 393427000
Fax 153256 0
Email 153256 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.