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

U

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

Trial contacts and locations

0

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Central trial contact

Kieron D Rooney, MBBS

Data sourced from clinicaltrials.gov

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