Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Short peptide enteral nutrition, Whole protein enteral nutrition.
- Who it may be relevant to
- Registry conditions: Sepsis, Nutrition. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Dietary supplement Short peptide 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 e - Dietary supplement Whole protein enteral nutrition
The whole protein formula enteral nutrition was initiated within 48 hours of admission to the ICU, and the rest were same.
Primary outcome measures
- Metabolomics changes form [Time frame: On the 7th day after enrollment]
Secondary outcome measures (12)
- Daily average protein intake [Time frame: 7 days]
- Daily average energy intake [Time frame: 7 days]
- Energy adequacy rate [Time frame: On the 3rd and 7th day after enrollment]
- Inflammatory markers [Time frame: 7 days]
- Nutritional status [Time frame: 7 days]
- Liver function [Time frame: 7 days]
- Renal function [Time frame: 7 days]
- Enteral nutritional tolerance rate [Time frame: 7 days]
- Skeletal muscle depletion condition [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]
Eligibility criteria
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..)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07038057 · B2025-213R