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

Ketosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02763553
• Other study ID #: AN/2015/5042
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 26, 2016
• Last updated: November 8, 2016
• Start date: December 2016
• Est. completion date: March 2017

Study information

• Verified date: November 2016
• Source: University Hospitals Bristol NHS Foundation Trust
• Contact: Kieron D Rooney, MBBS
• Phone: +44 117 342 7137
• Email: Kieron.Rooney[@]UHBristol.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ketosis

Intervention

Dietary Supplement:
• Ketogenic Feed
A low-carbohydrate, high-fat feed designed to induce a ketotic state.
• Standard Feed
Standard enteral feed used in critical care patients requiring nutrition via a nasogastric tube

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Bristol NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median serum ketone level	Serum ketone levels (mmol/L) will be recorded 4-hourly in each group. The median serum ketone level (mmol/L) will be calculated.	14 days	No
Secondary	Time to achieve serum ketosis	Time taken (hours) to achieve a clinically relevant ketosis (serum ketone > 0.3mmol/L) from introduction of an enteral ketogenic feed.	14 days	No