Clinical trial NCT02763553: Does a Ketogenic Diet Causes Ketosis in Patients on Intensive Care?
Official title: Does a Ketogenic Diet Reduce Delirium in Intensive Care? Part 1: - A Feasibility Study to Test if a Ketogenic Diet Causes Ketosis in Patients on Intensive Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ketosis
Keywords: Ketone Bodies
Enteral Nutrition
Ketogenic Diet
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Median serum ketone level
timeFrame: 14 days
Secondary outcomes:
measure: Time to achieve serum ketosis
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals Bristol and Weston NHS Foundation Trust
name: Kieron D Rooney, MBBS
role: STUDY_CHAIR
References: