Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT07038057
Brief Summary:
To explore the effects of early enteral nutrition with short peptide formula on energy metabolism and clinical outcomes in patients with sepsis based on blood samples, clinical database, full-spectrum metabolomics test and imaging data, and to form a theoretical basis for optimizing the formula of early enteral nutrition in patients with sepsis.
Detailed Description:
This study is a single-center prospective trial. Based on the annual patient volume, available human resources, and funding at our research center, the expert team determined a sample size of 80 cases, with 40 cases in the experimental group and 40 in the control group. Eligible participants will be randomized 1:1 via computer-generated randomization into two groups, receiving either a short-peptide-based enteral nutrition formula or a whole-protein-based enteral nutrition formula.
Short-peptide formula group:
Within 48 hours of ICU admission, short-peptide-based enteral nutrition (Peptisorb) will be initiated. For patients with impaired swallowing or unconsciousness, a nasogastric tube will be placed. Feeding will start with low-calorie or trophic feeding, reaching 70% of the target energy and 1.2-1.5 g/kg/day of protein within 7 days. Due to significant individual variability in energy expenditure among sepsis patients, indirect calorimetry (IC) will be used to measure energy needs. If IC is unavailable, a weight-based formula (20-25 kcal/kg/day) will be applied. If patients remain in the ICU after 7 days, feeding will be gradually increased to full energy and protein targets as tolerated, followed by a transition to whole-protein nutrition.
Whole-protein formula group:
Within 48 hours of ICU admission, whole-protein-based enteral nutrition (Nutrison) will be initiated, with the remaining protocol identical to the short-peptide group.
The study will assess changes in metabolomics after 7 days of early enteral nutrition with different protein formulations in sepsis patients, as well as differences in nutritional status, biochemical markers, and short- and long-term clinical outcomes.
Study:
NCT07038057
Study Brief:
Protocol Section:
NCT07038057