NCT02763553

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ketosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketogenic Feed	A low-carbohydrate, high-fat feed designed to induce a ketotic state.
DIETARY_SUPPLEMENT	Standard Feed	Standard enteral feed used in critical care patients requiring nutrition via a nasogastric tube

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2016-05-05
• Last updated: 2016-11-09