None listed
Conditions
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.
Interventions
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 o
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
Sponsors
Hayden White
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years or older Severe acute brain injury requiring ICU admission and mechanical ventilation Life expectancy of at least 72 hours
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
Outcome results
None listed