Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000332426
Ethics application status
Approved
Date submitted
9/03/2016
Date registered
15/03/2016
Date last updated
17/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of inducing Ketogenesis in patients with Acute Brain Injury via oral administration of a ketogenic feed.
Scientific title
Efficacy of inducing Ketogenesis in patients with Acute Brain Injury via oral administration of a ketogenic feed.
Secondary ID [1] 288723 0
None
Universal Trial Number (UTN)
Trial acronym
KABI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute brain injury 297960 0
Condition category
Condition code
Neurological 298119 298119 0 0
Other neurological disorders
Metabolic and Endocrine 298132 298132 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following admission to ICU, 20 patients with acute brain injury will be administered the ketogenic formulation via nasogastric tube as a continuous infusion (see below). The feeding goal will be determined by the ICU dietician. In all other aspects, the PAH feeding protocol will be followed. The infusion will continue for a maximum of 7 days or until nasogastric tube removal. Observations will be continued for a further 24 hours.

The feeding formulation will be made up as follows:
Use example of a 70 kg patient who requires 125kj/kg, aim 1.2g/kg protein:- 8750 kj/day and 84g protein ( ICU recommendations are 1.2 - 1.5g/kg)

USING LIQUID:
Liquid 200ml product Ketocal 4:1.
Ketocal provides (6.02 kj/ml) therefore require 1453 ml per day = 7.265 packets of 200ml each.
Ketocal provides 31g protein per litre, so total protein in the day is 45g protein from 1453 ml
The protein provided by Ketocal alone is insufficient.
Therefore extra 39g protein is required per day.
This would be from Protifar - which provides 2.2 g protein from 2.5 scoops
Therefore need 17.7 or approx 18 scoops of protifar per day - 18 scoops
Need 2.57 scoops per 200ml pack of Ketocal 4:1 each scoop weighs 2.2g.

Standard feeds (which will not be utilized during the trial) include Nutrison Multi Fibre which supplies 4300 kJ/L and consists of 40g protein, 123g CHO and 39g fat per liter
The primary difference between this and ketocal is that the calories are obtained from CHO whereas ketogenic feeds are high in fats with minimal CHO content
Intervention code [1] 294159 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297625 0
Beta-hydroxybutyrate and levels in blood and cerebrospinal fluid (EVD present)
Timepoint [1] 297625 0
Measured daily for 7 days
Primary outcome [2] 297640 0
Acetoacetate levels in blood and cerebrospinal fluid (EVD present)
Timepoint [2] 297640 0
Measured daily for 6 days
Secondary outcome [1] 321611 0
Blood glucose
Timepoint [1] 321611 0
Measured daily for seven days

Eligibility
Key inclusion criteria
18 years or older
Severe acute brain injury requiring ICU admission and mechanical ventilation
Life expectancy of at least 72 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Failure to obtain written consent from patient or substitute decision maker
Pregnancy (For women of child bearing age a pregnancy test will be obtained prior to commencement)
Non-survivable injury or brain death
Patients considered for organ donation
Acute liver failure or chronic liver disease (Childs B or C)
Patients whom enteral intake is not possible within 24 hours
Type I diabetes

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2016
Actual
17/06/2016
Date of last participant enrolment
Anticipated
Actual
9/06/2017
Date of last data collection
Anticipated
Actual
1/11/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5412 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 293074 0
Hospital
Name [1] 293074 0
Logan Hospital ICU research fund
Country [1] 293074 0
Australia
Primary sponsor type
Individual
Name
Hayden White
Address
Logan Hospital
Armstrong Rd
Meadowbrook
QLD 4131
Country
Australia
Secondary sponsor category [1] 291855 0
None
Name [1] 291855 0
none
Address [1] 291855 0
none
Country [1] 291855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294582 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 294582 0
Princess Alexandra Hospital
Metro South Hospital and Health Service
Queensland Government
Level 7 TRI, 37 Kent Street
WOOLLOONGABBA QLD 4102
Ethics committee country [1] 294582 0
Australia
Date submitted for ethics approval [1] 294582 0
08/01/2016
Approval date [1] 294582 0
23/02/2016
Ethics approval number [1] 294582 0
HREC/16/QPAH/30

Summary
Brief summary
Ketogenesis is the process by which ketone bodies, during times of starvation, are produced via fatty acid metabolism. Although much feared by physicians, mild ketosis can have therapeutic potential in a variety of disparate disease states. The principle ketones include acetoacetate (AcAc), Beta-hydroxybutyrate (BHB) and acetone. In times of starvation and low insulin levels, ketones supply up to 50% of basal energy requirements for most tissues, and up to 70% for the brain. Other than glucose, ketones are the only substances capable of fulfilling the energy requirements of the brain.

We have previously demonstrated that the ketone levels in adults with acute brain injury (ABI) are low. The aim of this study is to provide a feeding regimen that has the potential to increase ketone levels in patients with ABI.

20 patients with ABI admitted to Princess Alexandra Hospital Intensive Care Unit will be included. Each patient will be fed with an enteral formulation consisting of ketocal and protifar (produced by Nutricia Australia), which will provide the necessary energy and protein requirements. Both feeds are commercially available in Australia and used extensively in the paediatric population. The major difference between this feed and standard feed is the lack of carbohydrates to stimulate ketogenesis. The feeds will be continued for 7 days or until the patient is extubated or discharged from ICU. We will be measuring ketone levels and a number of other metabolites on a daily basis. Our goal is to demonstrate that this feeding regimen is capable of inducing ketosis in adults.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64254 0
Dr Hayden White
Address 64254 0
Logan Hospital
Armstrong Rd
Meadowbrook QLD
4131
Country 64254 0
Australia
Phone 64254 0
+61732998899
Fax 64254 0
Email 64254 0
[email protected]
Contact person for public queries
Name 64255 0
Dr Hayden White
Address 64255 0
Logan Hospital
Armstrong Rd
Meadowbrook QLD
4131
Country 64255 0
Australia
Phone 64255 0
+61732998899
Fax 64255 0
Email 64255 0
[email protected]
Contact person for scientific queries
Name 64256 0
Dr Hayden White
Address 64256 0
Logan Hospital
Armstrong Rd
Meadowbrook QLD
4131
Country 64256 0
Australia
Phone 64256 0
+61732998899
Fax 64256 0
Email 64256 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseInducing ketogenesis via an enteral formulation in patients with acute brain injury:a phase II study.2020https://dx.doi.org/10.1080/01616412.2019.1709743
N.B. These documents automatically identified may not have been verified by the study sponsor.