DeliKet Study (substudy KetoNiFast Study): Impact of cyclic enteral daytime feeding with ketogenic nighttime fasting on the development of perioperative delirium of critical ill patients.

DeliKet Study (substudy KetoNiFast Study): Impact of cyclic enteral daytime feeding with ketogenic nighttime fasting on the development of perioperative delirium of critical ill patients. - DeliKet Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034736

Enrollment

Registered

2024-07-25

Start date

2024-09-09

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F05

Interventions

Group 1: Interventional group 12 hours of enteral feeding (as per patients´individual calorimetric requirements measured by indirect calorimetry) from 6am-6pm followed by a fasting period of 12 hours

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -written informed consent to participate in this study -admission to ICU -enteral nutrition

Exclusion criteria

Exclusion criteria: -Severe liver dysfunction / liver failure (Child Pugh >7 points / category B) -severe kidney dysfunction (KDIGO stage 3) -Total pancreatectomy / insulin dependent diabetes mellitus (IDDM) -Pregnancy / lactation -Hemoglobin concentration < 80g/l -Severe metabolic disorders / severe autoimmune diseases -Refractory metabolic or respiratory acidosis -Dysfunction of mitochondrial transport of fatty acids -Dysfunction of oxidation of fatty acids -Dysfunction of gluconeogenesis, production and reduction of ketones -Intermittent Porphyria -Severe cardiac arrhythmias / cardiomyopathy -Contraindication against enteral nutrition -Lack of informed consent

Design outcomes

Primary

Measure	Time frame
•Cognitive function (CAM ICU score) day 1-day 14 •Cognitive function (MoCA- and MMST- Score) day 1, 7, 14 / ICU discharge Primary endpoints are patient- centered outcomes regarding cognitive function and signs of delirium.	—

Secondary

Measure	Time frame
• Length of invasive and noninvasive ventilation • Length of ICU- and hospital stay. • 30-day mortality	—

Countries

Germany

Contacts

Public ContactSandra Emily Stoll

Klinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Köln, Deutschland

sandra.stoll@uk-koeln.de+4922147882054

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026