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NCT Number: NCT07038057

Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis

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.

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Key information

Conditions

Sepsis Infections Inflammation Nutrition Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent has been signed
  • Aged from 18 to 80 years old
  • Within 24 hours after admission to ICU
  • Sepsis was diagnosed according to the 2016 International Sepsis 3.0 diagnostic criteria
  • Without gastrointestinal perforation, bleeding, obstruction and other contraindications to enteral nutrition
  • Expected ICU stay for more than 7 days

Exclusion criteria

  • Receiving palliative care or expected to die within 72 hours
  • Pregnant or breastfeeding
  • Use of high dose vasopressor maintenance (norepinephrine dosage > 0.5 μg/kg/min)
  • Requiring restricted protein intake or additional protein supplementation (e.g., patients with hepatic encephalopathy, severe renal insufficiency, severe burns, severe malnutrition, etc..)

Treatment and study plan

Short peptide enteral nutrition

Dietary Supplement

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.

Whole protein enteral nutrition

Dietary Supplement

The whole protein formula enteral nutrition was initiated within 48 hours of admission to the ICU, and the rest were same.

Primary outcomes

  1. Metabolomics changes form

    Time frame: On the 7th day after enrollment

    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.

Secondary outcomes

  1. Daily average protein intake

    Time frame: 7 days

    Daily average protein intake, including EN, PN, IVAA, and measurable oral protein supplements; oral diets with unquantifiable protein content excluded (Unit: g).

  2. Daily average energy intake

    Time frame: 7 days

    Daily average energy intake (Unit: g).

  3. Energy adequacy rate

    Time frame: On the 3rd and 7th day after enrollment

    Energy adequacy rate on the 3rd and 7th day after enrollment (Unit: %).

  4. Inflammatory markers

    Time frame: 7 days

    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).

  5. Nutritional status

    Time frame: 7 days

    Albumin (Alb) (Unit: g/L) and Pre-albumin (PA) (Unit: mg/L).

  6. Liver function

    Time frame: 7 days

    Bilirubin (BIL) (Unit: μmol/L)

  7. Renal function

    Time frame: 7 days

    Blood urea nitrogen (BUN) (Unit: mmol/L) and Serum creatinine (Cr) (Unit: umol/L).

  8. Enteral nutritional tolerance rate

    Time frame: 7 days

    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.

  9. Skeletal muscle depletion condition

    Time frame: 7 days

    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.

  10. Days of ventilator use

    Time frame: 28 days

  11. 28-day all-cause mortality rate

    Time frame: 28 days

  12. All-cause mortality at 90 days

    Time frame: 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

JieQiong Song, MD, PhD

CONTACT

[email protected]

+86 13917056745

Yanni Zhang, MD, PhD

CONTACT

[email protected]

+86 13381819621

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis: a Single-Center, Prospective, Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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