Does a Ketogenic Diet Causes Ketosis in Patients on Intensive Care?
Primary Purpose
Ketosis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ketogenic Feed
Standard Feed
Sponsored by
About this trial
This is an interventional treatment trial for Ketosis focused on measuring Ketone Bodies, Enteral Nutrition, Ketogenic Diet
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ketogenic Feed
Standard Feed
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02763553
First Posted
April 26, 2016
Last Updated
November 8, 2016
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02763553
Brief Title
Does a Ketogenic Diet Causes Ketosis in Patients on Intensive Care?
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis
Keywords
Ketone Bodies, Enteral Nutrition, Ketogenic Diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic Feed
Arm Type
Experimental
Arm 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.
Arm Title
Standard Feed
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic Feed
Other Intervention Name(s)
Nutrison KetoCal 4:1
Intervention Description
A low-carbohydrate, high-fat feed designed to induce a ketotic state.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard Feed
Other Intervention Name(s)
Nutrison ProteinPlus MultiFibre 1.28
Intervention Description
Standard enteral feed used in critical care patients requiring nutrition via a nasogastric tube
Primary Outcome Measure Information:
Title
Median serum ketone level
Description
Serum ketone levels (mmol/L) will be recorded 4-hourly in each group. The median serum ketone level (mmol/L) will be calculated.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time to achieve serum ketosis
Description
Time taken (hours) to achieve a clinically relevant ketosis (serum ketone > 0.3mmol/L) from introduction of an enteral ketogenic feed.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kieron D Rooney, MBBS
Phone
+44 117 342 7137
Email
Kieron.Rooney@UHBristol.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kieron D Rooney, MBBS
Organizational Affiliation
University Hospitals Bristol and Weston NHS Foundation Trust
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
No, anonymised data only
Learn more about this trial
Does a Ketogenic Diet Causes Ketosis in Patients on Intensive Care?
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