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

Sponsor
University Hospital of Cologne
Study ID
NCT06535022
Status
Not Yet Recruiting

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Conditions

  • Delirium
  • Ketogenic Dieting
  • Nutrition, Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 2, 2024
Start date
Sep 1, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Mar 1, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Interventional group: Cyclic enteral nutrition with ketogenic nighttime fasting
    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.
  • No Intervention: Control group: Conventional continuous enteral nutrition
    Continuous (24 hours) enteral nutrition in the Intensive Care Setting.

Primary Outcome Measure

Confusion Assessment Method (CAM- ICU) [ Time Frame: Day 1-14 after randomization or until ICU discharge ]

Central Contacts

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