A sample size of 318 patients is expected for the ongoing trial comparing daily cyclic enteral nutrition and standard continuous enteral nutrition in ICU patients.
The trial aims to evaluate if a fasting-mimicking diet can reduce organ failure in ventilated patients during the acute phase of ICU management.
Primary endpoint is the change in the score at 7 days from study inclusion.
Secondary outcomes include daily caloric and protein delivery, digestive and respiratory tolerance, metabolic tolerance, 28-day mortality, duration of mechanical ventilation, and ventilator-free days.
Patients involved are aged 18 years or older, receiving invasive mechanical ventilation, and require enteral nutrition.
Simplified
INTRODUCTION: Current guidelines on clinical nutrition of ventilated patients in the intensive care unit (ICU) recommend initiating continuous enteral nutrition within 48 hours of ICU admission when feasible. However, discontinuous feeding regimens, alternating feeding and fasting intervals, may have an impact on clinical and patient centred outcomes. The ongoing "Impact of daily cyclic enteral nutrition versus standard continuous enteral nutrition in critically ill patients" (DC-SCENIC) trial aims to compare standard continuous enteral feeding with daily cyclic enteral feeding over 10 hours to evaluate if implementing a fasting-mimicking diet can decrease organ failure in ventilated patients during the acute phase of ICU management.
METHODS AND ANALYSIS: DC-SCENIC is a randomised, controlled, multicentre, open-label trial comparing two parallel groups of patients 18 years of age or older receiving invasive mechanical ventilation and having an indication for enteral nutrition through a gastric tube. Enteral feeding is continuous in the control group and administered over 10 hours daily in the intervention group. Both groups receive isocaloric nutrition with 4 g of protein per 100 mL, and have the same 20 kcal/kg/day caloric target. The primary endpoint is the change in the score at 7 days compared with the day of inclusion in the study. Secondary outcomes include daily caloric and protein delivery, digestive, respiratory and metabolic tolerance as well as 28-day mortality, duration of mechanical ventilation and ventilator-free days. Outcomes will be analysed on an intention-to-treat basis. Recruitment started in June 2023 in 3 French ICU's and a sample size of 318 patients is expected by February 2026.
ETHICS AND DISSEMINATION: This study received approval from the national ethics review board on 8 November 2022 (Comité de Protection des Personnes Sud-Est VI, registration number 2022-A00827-36). Patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER: NCT05627167.
Key numbers
318
Sample Size
Total number of patients expected to be recruited by February 2026.
4 vs. 6
Primary Endpoint Change in Score
Estimated mean Δ scores for continuous and daily cyclic feeding groups.
Full Text
We can’t show the full text here under this license.
