None listed
Conditions
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.
Interventions
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
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.
Sponsors
Sir Charles Gairdner Hospital, Western Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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)
Outcome results
None listed