An interventional study of Short peptide enteral nutrition and Whole protein enteral nutrition in Sepsis and Nutrition, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 80 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: Short peptide enteral nutrition
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.
Dietary Supplement: Whole protein enteral nutrition
Short peptide formula enteral nutrition was initiated within 48 hours after admission to the ICU. For patients with poor swallowing function or no consciousness, nasogastric tubes were placed. Starting from low-calorie or nourishing feeding, 70% of the target energy should be achieved within 7 days, and the protein should be 1.2-1.5 g/kg/d. Due to the large individual differences in energy expenditure among patients with sepsis, the indirect calorimetry (IC) method was used to determine energy expenditure. If the IC method is not feasible, the calculation formula based on body weight: 20-25 kcal/kg/d should be applied for calculation. If the patient is not transferred out of the ICU after 7 days, continue to gradually increase to the target energy and protein requirements under tolerable conditions, and gradually transition to whole protein nutrition after 7 days.
The whole protein formula enteral nutrition was initiated within 48 hours of admission to the ICU, and the rest were same.
Metabolomics changes form
Key assessments include: ① Concentration changes of differential metabolites in core pathways (BCAA, SCFA, bile acid metabolism); ② Correlation between metabolite fluctuations and nutritional markers (albumin, prealbumin); ③ Predictive modeling linking metabolic signatures to clinical outcomes (infection rate, ICU LOS). The above data were all normalized and ultimately presented in the form of a heatmap.
Time frame: On the 7th day after enrollment
Daily average protein intake
Daily average protein intake, including EN, PN, IVAA, and measurable oral protein supplements; oral diets with unquantifiable protein content excluded (Unit: g).
Time frame: 7 days
Daily average energy intake
Daily average energy intake (Unit: g).
Time frame: 7 days
Energy adequacy rate
Energy adequacy rate on the 3rd and 7th day after enrollment (Unit: %).
Time frame: On the 3rd and 7th day after enrollment
Inflammatory markers
Including C-reactive protein (CRP) (Unit: mg/L), White blood cell count (WBC) (Unit: \*10\^9/L), and Neutrophil count (Neut#) (Unit: \*10\^9/L).
Time frame: 7 days
Nutritional status
Albumin (Alb) (Unit: g/L) and Pre-albumin (PA) (Unit: mg/L).
Time frame: 7 days
Liver function
Bilirubin (BIL) (Unit: μmol/L)
Time frame: 7 days
Renal function
Blood urea nitrogen (BUN) (Unit: mmol/L) and Serum creatinine (Cr) (Unit: umol/L).
Time frame: 7 days
Enteral nutritional tolerance rate
Manifestations of enteral nutrition intolerance: Gastric retention (gastric residual volume \> 500 mL within 4 hours) Severe nausea or vomiting; Abdominal distension; Diarrhea (≥ 3 bowel movements per day with loose stools, Bristol Stool Scale type 5-7); Hematochezia leading to hemodynamic instability.
Time frame: 7 days
Skeletal muscle depletion condition
A single cross-sectional image at the L3 level was obtained via CT scan. Skeletal muscle was identified and quantified within the image using Hounsfield Unit (HU) thresholds of -29 to +150. The total muscle area at this level was calculated using ImageJ image analysis software. After normalization by the square of height (m²), the third lumbar skeletal muscle index (L3-SMI) was derived.
Time frame: 7 days
Days of ventilator use
Time frame: 28 days
28-day all-cause mortality rate
Time frame: 28 days
All-cause mortality at 90 days
Time frame: 90 days
No study locations are listed for this record.
Plan to share: No
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Shanghai Zhongshan Hospital