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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of Cologne

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Admission to an ICU

Start of enteral nutrition

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

90 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University Hospital of Cologne

Lead sponsor