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

NCT07038057 | Not Yet Recruiting DMC

• 1 other identifier: B2025-213R
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis; Nutrition

Outcome Measures

Primary Outcomes (1)

• 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.

  On the 7th day after enrollment

Secondary Outcomes (12)

• Daily average protein intake

  7 days

• Daily average energy intake

  7 days

• Energy adequacy rate

  On the 3rd and 7th day after enrollment

• Inflammatory markers

  7 days

• Nutritional status

  7 days

Study Arms (2)

Short peptide formula

EXPERIMENTAL

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

Whole protein formula

ACTIVE COMPARATOR

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

Interventions

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.

Short peptide formula

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.

Whole protein formula

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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..)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yanni Zhang, MD, PhD

CONTACT

+86 13381819621; yanni99@126.com

JieQiong Song, MD, PhD

CONTACT

+86 13917056745; song.jieqiong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 26, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share