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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033189
Enrollment
130
Registered
2023-12-11
Start date
2023-12-11
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

OPS 8-017Enteral nutrition

Interventions

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

Sponsors

Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinikum Köln
Lead Sponsor

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

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

Secondary

MeasureTime frame
-Length of invasive and noninvasive ventilation -Length of ICU and hospital stay -30 day mortality on day 30 -ICU mobility scale on discharge on day 3, 7, 10, 14 -SF-36 (questionnaire) on day of study inclusion and on day 30

Countries

Germany

Contacts

Public ContactSandra Emily Stoll

Klinik für Anästhesiologie und Operative Intensivmedizin Uniklinikum Köln

direktor-anaesthesiologie-vorzimmer@uk-koeln.de+4922147882054

Outcome results

None listed

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