KetoNiFast Study: Impact of cyclic enteral daytime feeding with ketogenic nighttime fasting on outcome of critical ill patients.

Early Phase 1

Recruiting

• Conditions: OPS 8-017Enteral nutrition

• Registration Number: DRKS00033189
• Lead Sponsor: Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinikum Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

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
-Loss of muscle mass (measured on day 3, 7,10 and 14 via Ultrasound of M. <br> rectus femoris of a predefined leg)<br>-Urea / creatinine ratio in the patients´ blood measured on day 3, 7, 10 and 14

Secondary Outcome Measures

Name	Time	Method
-Length of invasive and noninvasive ventilation<br>-Length of ICU and hospital stay<br>-30 day mortality on day 30<br>-ICU mobility scale on discharge on day 3, 7, 10, 14<br>-SF-36 (questionnaire) on day of study inclusion and on day 30