DeliriumDeliKetNCT06535022
DeliKet (Substudy of KetoNiFast Study ID 22-1398_1)
A study testing Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate) in people with Delirium and Ketogenic Dieting, run by University Hospital of Cologne.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Ketogenic Dieting, Nutrition, Healthy
- What is being tested?
- Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Admission to an ICU
- Start of enteral nutrition
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Cyclic, Daytime Enteral Nutrition and Ketogenic Nighttime Fasting on the Incidence of Postoperative Delirium in Critically Ill Patients
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.
Read the 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.
- Conditions
- Delirium, Ketogenic Dieting, Nutrition, Healthy
- Being tested
- Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)
- Keywords
- ketogenic diet, cyclic nutrition, postoperative delirium
- Medical subject headings
- Delirium, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)Dietary supplement
Also called cyclic nutrition with nighttime fasting and exogenous ß-hydroxybutyrate supplementation
Nighttime fasting and ß-hydroxybutyrate supplementation
| Study group | Role | What they receive |
|---|---|---|
| Interventional group: Cyclic enteral nutrition with ketogenic nighttime fasting | Experimental | Interventional group: Cyclic enteral daytime nutrition (12 hours) with ketogenic nighttime fasting (12 hours) with supplementation of exogenous ketones (ß-hydroxybutyrate) in the Intensive Care Setting. Receives: Dietary Supplement: Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate) |
| Control group: Conventional continuous enteral nutrition | No intervention | Continuous (24 hours) enteral nutrition in the Intensive Care Setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confusion Assessment Method (CAM- ICU)
CAM ICU score (lowest score 0, highest score 7)
- Cognitive function (MoCA- and MMST- Score) day 1, 7, 14 / ICU discharge
Measured: Day 1-14 after randomization or until ICU discharge
• Montreal Cognitive Assessment (MoCA- Score)
- Cognitive function (MoCA- Score) (lowest Score 0, highest Score 30)
Measured: Day 1-14 after randomization or until ICU- discharge
MMSE (Minimental State Examination)
MMSE Score (lowest Score 0, highest Score 30)
Measured: Day 1-14 after randomization or until ICU discharge
Secondary outcomes (3)
Duration of ventilation
Length of invasive and noninvasive ventilation
Measured: From day of randomization until ICU discharge up to 1 month
Length of ICU- and Hospital stay
Length of ICU- and Hospital stay
Measured: From day of randomization until hospital discharge up to 6 months
30-day mortality
Mortality at day 30 after ICU admission
Measured: From day of randomization up until 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, monocentric, interventional study
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Emily Stoll, University Hospital of Cologne
- Investigators
- Bernd W Böttiger, Prof, Study director, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535022
- Sponsor's protocol ID
- 22-1398_2
- Acronym
- DeliKet
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cyclic, Daytime Enteral Nutrition and Ketogenic Nighttime Fasting on the Incidence of Postoperative Delirium in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06535022
- Acronym / sponsor ID
- DeliKet / 22-1398_2
- Conditions
- Delirium, Ketogenic Dieting, Nutrition, Healthy
- Keywords
- ketogenic diet, cyclic nutrition, postoperative delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, monocentric, interventional study
| Arm | Type | Receives |
|---|---|---|
| Interventional group: Cyclic enteral nutrition with ketogenic nighttime fasting | Experimental | Dietary Supplement: Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)Interventional group: Cyclic enteral daytime nutrition (12 hours) with ketogenic nighttime fasting (12 hours) with supplementation of exogenous ketones (ß-hydroxybutyrate) in the Intensive Care Setting. |
| Control group: Conventional continuous enteral nutrition | No intervention | –Continuous (24 hours) enteral nutrition in the Intensive Care Setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Admission to an ICU
- Start of enteral nutrition
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)Also: cyclic nutrition with nighttime fasting and exogenous ß-hydroxybutyrate supplementationNighttime fasting and ß-hydroxybutyrate supplementation | Dietary supplement | Interventional group: Cyclic enteral nutrition with ketogenic nighttime fasting |
Primary outcome
Confusion Assessment Method (CAM- ICU)
Time frame: Day 1-14 after randomization or until ICU discharge
CAM ICU score (lowest score 0, highest score 7) • Cognitive function (MoCA- and MMST- Score) day 1, 7, 14 / ICU discharge
• Montreal Cognitive Assessment (MoCA- Score)
Time frame: Day 1-14 after randomization or until ICU- discharge
• Cognitive function (MoCA- Score) (lowest Score 0, highest Score 30)
MMSE (Minimental State Examination)
Time frame: Day 1-14 after randomization or until ICU discharge
MMSE Score (lowest Score 0, highest Score 30)
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd W Böttiger, Prof study director
University Hospital of Cologne
Questions about this trial
What is this clinical trial studying?
A study testing Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate) in people with Delirium and Ketogenic Dieting, run by University Hospital of Cologne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra E Stoll, MD, assProf. (+49221478 ext. 82054, sandraemilystoll@googlemail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confusion Assessment Method (CAM- ICU) (time frame: Day 1-14 after randomization or until ICU discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.