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
1 other identifier
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2016
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedNovember 9, 2016
November 1, 2016
1 month
April 26, 2016
November 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Time to achieve serum ketosis
14 days
Study Arms (2)
Ketogenic Feed
EXPERIMENTALA 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 Feed
ACTIVE COMPARATORStandard 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.
Interventions
A low-carbohydrate, high-fat feed designed to induce a ketotic state.
Standard enteral feed used in critical care patients requiring nutrition via a nasogastric tube
Eligibility Criteria
You may qualify if:
- Adults who require mechanical ventilation within 72 hours of admission to intensive care
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kieron D Rooney, MBBS
University Hospitals Bristol and Weston NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2016
First Posted
May 5, 2016
Study Start
December 1, 2016
Primary Completion
January 1, 2017
Study Completion
March 1, 2017
Last Updated
November 9, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
No, anonymised data only