DeliKet (Substudy of KetoNiFast Study ID 22-1398_1)

NCT06535022 | Not Yet Recruiting

• 1 other identifier: 22-1398_2
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Delirium; Ketogenic Dieting; Nutrition, Healthy

Keywords

ketogenic diet; cyclic nutrition; postoperative delirium

Outcome Measures

Primary Outcomes (3)

• 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

  Day 1-14 after randomization or until ICU discharge

• • Montreal Cognitive Assessment (MoCA- Score)

  • Cognitive function (MoCA- Score) (lowest Score 0, highest Score 30)

  Day 1-14 after randomization or until ICU- discharge

• MMSE (Minimental State Examination)

  MMSE Score (lowest Score 0, highest Score 30)

  Day 1-14 after randomization or until ICU discharge

Secondary Outcomes (3)

• Duration of ventilation

  From day of randomization until ICU discharge up to 1 month

• Length of ICU- and Hospital stay

  From day of randomization until hospital discharge up to 6 months

• 30-day mortality

  From day of randomization up until 30 days

Study Arms (2)

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.

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.

Interventions

Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate) DIETARY_SUPPLEMENT

Nighttime fasting and ß-hydroxybutyrate supplementation

Also known as: cyclic nutrition with nighttime fasting and exogenous ß-hydroxybutyrate supplementation

Interventional group: Cyclic enteral nutrition with ketogenic nighttime fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Admission to an ICU
• Start of enteral nutrition

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Cologne: lead

MeSH Terms

Conditions

Delirium; Emergence Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Study Officials

• Bernd W Böttiger, Prof

  University Hospital Cologne

  STUDY DIRECTOR

Central Study Contacts

Sandra E Stoll, MD, assProf.

CONTACT

+49221478; sandraemilystoll@googlemail.com

Fabian Dusse, PD, MD

CONTACT

+49221478; fabian.dusse@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: sealed, opaque envelopes
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ass. Professor

Model Details: Prospective, randomized, monocentric, interventional study

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share