Ketosis
Conditions
Keywords
Ketone Bodies, Enteral Nutrition, Ketogenic Diet
Brief summary
The purpose of this study is to assess if an enteral ketogenic feed will cause a ketotic state in critically ill patients on intensive care.
Detailed description
This pilot study is a prospective, single-centre, unblinded, parallel-group, randomised controlled, Phase IIb trial comparing standard enteral nutrition with an enteral ketogenic feed. The trial has a simple, pragmatic design and will be analysed on an intention-to-treat basis. It aims to recruit 10 patients from a single University teaching hospital adult general ICU. The anticipated recruitment period is 4 weeks. Adult patients admitted to intensive care and expected to require enteral feed via a nasogastric tube for at least 5 days and who fulfil other eligibility criteria will be allocated at random to receive either standard feed (Nutrison Protein Plus Multi Fibre) or a ketogenic enteral feed (Nutrison KetoCal 4:1). The primary endpoint will be increase in ketone body concentration in serum. Secondary endpoints will include, time taken to achieve a ketotic state, ketone levels in critical care patients who are not absorbing enteral feed, glucose levels in patients on a ketone feed, triglyceride and cholesterol levels, creatinine kinase levels and development of a metabolic acidosis. Adult ICU patients will be eligible to be included in this study if they are expected to require enteral feed via a nasogastric or nasojejunal tube or established percutaneous jejunostomy for at least 5 days. Practically, this will be achieved by screening ventilated patients as they will require enteral feeding Major exclusion criteria include contraindications to ketogenic feeds, contraindications to enteral feeding, a new (\< 5 days) percutaneous jejunostomy. The intervention will continue until 14 days if the patient still requires enteral nutrition or until able to commence a normal diet orally.
Interventions
DIETARY_SUPPLEMENTKetogenic Feed
A low-carbohydrate, high-fat feed designed to induce a ketotic state.
DIETARY_SUPPLEMENTStandard Feed
Standard enteral feed used in critical care patients requiring nutrition via a nasogastric tube
Sponsors
University Hospitals Bristol and Weston NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults who require mechanical ventilation within 72 hours of admission to intensive care
Exclusion criteria
* Known intolerance to the ketogenic diet * Contraindication to standard protocolised enteral feeding * Pregnancy * Severe liver disease (known decompensated liver cirrhosis, previous liver transplant, acute hepatitis (bilirubin \>100, ALT \>500) * Severe metabolic acidosis (pH \< 7.2, HCO3 \< 15mmol/L) that has not been corrected prior to enrolment in the study * Patients predicted to stay less than 24 hours on intensive care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median serum ketone level | 14 days | Serum ketone levels (mmol/L) will be recorded 4-hourly in each group. The median serum ketone level (mmol/L) will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve serum ketosis | 14 days | Time taken (hours) to achieve a clinically relevant ketosis (serum ketone \> 0.3mmol/L) from introduction of an enteral ketogenic feed. |
Contacts
Primary ContactKieron D Rooney, MBBS
Outcome results
None listed