Does a Ketogenic Diet Causes Ketosis in Patients on Intensive Care?

University Hospitals Bristol and Weston NHS Foundation Trust

Status and phase: Unknown; Phase 2

Conditions: Ketosis

Treatments: Dietary Supplement: Ketogenic Feed; Dietary Supplement: Standard Feed

Study type: Interventional

Funder types: Other

Identifiers

NCT02763553

AN/2015/5042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Ketogenic Feed

Experimental group

Description:

A low-carbohydrate, high-fat enteral feed (Nutrison KetoCal 4:1) containing 0.4g of carbohydrate and 10g of fat per 100kcal. Given as a continuous feed via a naso-gastric tube as per standard feeding protocol.

Treatment:

Dietary Supplement: Ketogenic Feed

Standard Feed

Active Comparator group

Description:

Standard enteral feed (Nutrison ProteinPlus MF 1.28) containing 11.1g of carbohydrate and 3.8g of fat per 100kcal. Given as a continuous feed via a naso-gastric tube as per standard feeding protocol.

Treatment:

Dietary Supplement: Standard Feed