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.

Not Applicable

• Conditions: F05; Delirium, not induced by alcohol and other psychoactive substances

• Registration Number: DRKS00034736
• Lead Sponsor: Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
•Length of invasive and noninvasive ventilation<br>•Length of ICU- and hospital stay.<br>•30-day mortality