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A Target Trial Emulation Study: The Effect of Amino Acid-Based Elemental Diet on Immune Function in Patients with Sepsis

A Target Trial Emulation Study: The Effect of Amino Acid-Based Elemental Diet on Immune Function in Patients with Sepsis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119139
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-02-24
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis

Interventions

Amino Acid-Based Elemental Enteral Nutrition Group:None
Intact Protein-Based Enteral Nutrition Group:None

Sponsors

Beijing Chaoyang Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. age >= 18 years; 2. meets the 2021 diagnostic criteria for sepsis 3.0; 3. expected ICU stay >= 48 hours; 4. have an indication for nutritional support (nutritional screening for risk of malnutrition NRS2002 >= 3 points) and require enteral nutritional support; 5. The patient or family member understands the study protocol and is willing to participate in the study by providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. those with a history of allergy to components in enteral nutrition; 2. those with severe disorders of the internal environment; 3. patients with severe diabetes mellitus, patients taking large amounts of steroids; 4. Pregnant and lactating women; 5. patients with abnormal amino acid metabolism; 6. uncontrolled shock, not yet haemodynamically stable or inadequate tissue perfusion; 7. uncontrolled fatal hypoxaemia, hypercapnia or acidosis; 8. presence of active upper gastrointestinal bleeding, significant gastrointestinal ischaemia, high-flow small bowel fistula, abdominal septal compartment syndrome; 9. gastrointestinal decompression drainage >= 500 ml/6h; 10. has been on parenteral nutritional support for >3 days.

Design outcomes

Primary

MeasureTime frame
T and B lymphocyte subsets;levels of inflammatory cytokines;HLA-DR expression on immune cells;Lymphocyte count;

Secondary

MeasureTime frame
Nutritional status parameters;ICU length of stay;Duration of mechanical ventilation;Duration of antibiotic therapy;28-day all-cause mortality after enrollment;Occurrence and timing of new-onset infections;Energy delivery adequacy rate;

Countries

China

Contacts

Public ContactNa Cui

Beijing Chaoyang Hospital Affiliated to Capital Medical University

cyyy_cn@163.com+86 85231458

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026