Health TrialsbyHealthPanel

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

ConditionsDeliriumKetogenic DietingNutrition, Healthy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Dietary supplement

    Nighttime fasting and ß-hydroxybutyrate supplementation

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Interventional group: Cyclic enteral nutrition with ketogenic nighttime fastingExperimental treatment 1 intervention
Group B: Control group: Conventional continuous enteral nutritionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1-14 after randomization or until ICU discharge
2

• Montreal Cognitive Assessment (MoCA- Score)

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

Time frame
Day 1-14 after randomization or until ICU- discharge
3

MMSE (Minimental State Examination)

MMSE Score (lowest Score 0, highest Score 30)

Time frame
Day 1-14 after randomization or until ICU discharge

Secondary outcomes

1

Duration of ventilation

Length of invasive and noninvasive ventilation

Time frame
From day of randomization until ICU discharge up to 1 month
2

Length of ICU- and Hospital stay

Length of ICU- and Hospital stay

Time frame
From day of randomization until hospital discharge up to 6 months
3

30-day mortality

Mortality at day 30 after ICU admission

Time frame
From day of randomization up until 30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital of Cologne

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: