DeliKet (Substudy of KetoNiFast Study ID 22-1398_1)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate).
- Who it may be relevant to
- Registry conditions: Delirium, Ketogenic Dieting, Nutrition, Healthy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Cyclic, Daytime Enteral Nutrition and Ketogenic Nighttime Fasting on the Incidence of Postoperative Delirium in Critically Ill Patients
Overview
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.
Detailed description
Postoperative delirium remains a common postoperative problem in critically ill patients with a prevalence of up to 20% and even up to 50% in the elderly population. But postoperative delirium has a negative impact on mortality as several studies were able to show in the past. Therefore, aiming for a reduction of postoperative delirium has an important impact on patients' outcome. One helpful tool for avoiding postoperative delirium is maintaining a circadian pattern. Enteral feeding may play an important role here. Healthy humans have a circadian feeding pattern with nighttime fasting. There is increasing evidence that a circadian rhythm of feeding (cyclic feeding) could be beneficial for critical ill patients. Cyclic feeding and fasting are assumed to have positive effects on the gut microbiome resulting in optimization of host responses to gastrointestinal pathogens. Another positive effect of cyclic feeding potentially results from activation of a "fasting response", inducing repair pathways such as ketogenesis, mitochondrial biogenesis, anti-inflammatory pathways, antioxidant defenses and autophagy processes. The activation of these repair pathways could diminish cellular stress and promote cellular recovery in critical ill patients. This could have a positive effect on postoperative delirium. A randomized controlled trial by van Dyck et al. could show that fasting-mimicking intervals of 12 hours are sufficient to generate a metabolic fasting response without risking a caloric deficit. This fasting response can be enhanced by additional supplementation of exogenous ketones. The study objective is that equicaloric cyclic enteral feeding (for 12 hours) during daytime with ketogenic fasting (for 12 hours) at nighttime (aiming for a ß-hydroxybutyrate blood concentrations ≥ 0.5mM by exogenous ketone supplementation) compared to continuous (for 24 hours) standard enteral nutrition as per patients' nutritional requirements decreases the incidence of postoperative delirium of critically ill patients.
Interventions
- Dietary supplement Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)
Nighttime fasting and ß-hydroxybutyrate supplementation
Primary outcome measures
- Confusion Assessment Method (CAM- ICU) [Time frame: Day 1-14 after randomization or until ICU discharge]
- • Montreal Cognitive Assessment (MoCA- Score) [Time frame: Day 1-14 after randomization or until ICU- discharge]
- MMSE (Minimental State Examination) [Time frame: Day 1-14 after randomization or until ICU discharge]
Secondary outcome measures (3)
- Duration of ventilation [Time frame: From day of randomization until ICU discharge up to 1 month]
- Length of ICU- and Hospital stay [Time frame: From day of randomization until hospital discharge up to 6 months]
- 30-day mortality [Time frame: From day of randomization up until 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06535022 · 22-1398_2