Clinical Trial: Does a Ketogenic Diet Causes Ketosis in Patients on Intensive Care?
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
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
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 Summary:
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.
Sponsor: University Hospitals Bristol NHS Foundation Trust
Current Primary Outcome: Median serum ketone level [ Time Frame: 14 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Time to achieve serum ketosis [ Time Frame: 14 days ]
Original Secondary Outcome: Same as current
Information By: University Hospitals Bristol NHS Foundation Trust
Dates:
Date Received: April 26, 2016
Date Started: December 2016
Date Completion: March 2017
Last Updated: November 8, 2016
Last Verified: November 2016