DeliKet (Substudy of KetoNiFast Study ID 22-1398_1) (NCT06535022) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
DeliKet (Substudy of KetoNiFast Study ID 22-1398_1)
90 participantsStarted 2024-09-01
Plain-language summary
Postoperative delirium is a common problem of the critically ill patient and associated with an increased mortality. Intermittent fasting and ketogenesis have been shown to be beneficial for maintaining a circadian rhythm and initiating anti-inflammatory repair mechanisms which could potentially be neuroprotective. However, so far there is little data if cyclic enteral feeding with ketogenic nighttime fasting might be beneficial for reducing the rate of postoperative delirium. The study hypothesis is that equicaloric cyclic enteral feeding (12 hrs) during daytime with ketogenic fasting and exogenous ketone supplementation at nighttime compared to continuous standard enteral nutrition (24 hours) decreases the incidence of postoperative delirium in critically ill patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Admission to an ICU
* Start of enteral nutrition
Exclusion Criteria:
* Severe liver insufficiency / liver disease (Child Pugh \> B or 7-9 points)
* Post total Pancreatectomy / Insulin-depending diabetes mellitus (IDDM)
* Pregnancy / Lactation
* Hemoglobin-concentration \< 80g/l
* Severe metabolic disorder / severe autoimmune disease
* Refractory respiratory or metabolic acidosis
* Disorder of mitochondrial transportation of fatty acids
* Disorder of the oxidation of fatty acids
* Disorder of gluconeogenesis, der ketone body production or ketone body degradation
* Intermittent porphyria
* Severe arrhythmia / cardiomyopathy
* Contraindications against enteral nutrition
* Missing informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it even make sense for me to wait for it given my current situation?
2This study seems to be testing a ketogenic diet as a way to prevent or address delirium, possibly in a hospital or ICU setting — based on my specific health situation, do you think a ketogenic diet approach is something realistic or safe for me to try?
3The trial is measuring delirium using tools like the CAM-ICU and cognitive assessments like the MoCA and MMSE — what do my current scores on those kinds of tests look like, and would that affect whether I might be a candidate for something like this?
4Since this appears to be a nutrition-focused substudy rather than a drug trial, are there known risks to a ketogenic diet for someone in my condition that I should understand before discussing participation with the research team?
5Are there standard-of-care approaches to preventing or managing delirium that I should consider first, rather than waiting for this study to begin enrolling?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Confusion Assessment Method (CAM- ICU)
Timeframe: Day 1-14 after randomization or until ICU discharge
2
• Montreal Cognitive Assessment (MoCA- Score)
Timeframe: Day 1-14 after randomization or until ICU- discharge
3
MMSE (Minimental State Examination)
Timeframe: Day 1-14 after randomization or until ICU discharge