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Neurocritical disease study of short peptide sequential protein enteral nutrition

A prospective,open label,randomized controlled studycomparing the efficacy and safety of sequential therapy ofisotonic and hypertonic short peptide enteral nutritionfollowed by high protein enteral nutrition products onneurological critically ill patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098585
Enrollment
Unknown
Registered
2025-03-11
Start date
2025-03-31
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Neurological critical illness

Interventions

Control group:Sequential of Enteral nutrition suspension (SP) (7 days treatment) followed by Enteral nutritional emulsion (TP-HE).
Treatment group:Sequential therapy of Enteral nutrition emulsion (SP) (7 days treatment) followed by Enteral nutritional emulsion (TP-HE) (totally up.

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with severe stroke diagnosed by head trauma and CT or MRI, Glasgow score (GCS) =30g/L, total protein >=60g/L; 3. The patient is unable to eat normally due to coma or other reasons and needs nutritional therapy, and according to the clinical judgment of the investigator, the patient is suitable for tube feeding nutrition for at least 14 days; 4.NRS2002>=3, or m NUTRIC score > 5; 5. Age: >=18 Y; 6. Body mass index 18.5 kg/m^2>=(BMI)<35kg/m^2; 7. Hemodynamically stable; 8. Agree to join the study and have informed consent signed by the surrogate.

Exclusion criteria

Exclusion criteria: 1. The patient has contraindications to enteral nutrition, such as intestinal slowness, intestinal obstruction, gastric bleeding, gastric perforation, complete gastrointestinal failure, severe abdominal infection and intractable diarrhea; 2. The patient is receiving EN treatment; 3. The patient is receiving intravenous human albumin therapy; 4. Patients receive parenteral nutrition (including total parenteral nutrition and partial parenteral nutrition); 5. Patients with hypoproteinemia of primary diseases; 6. Severe hepatic insufficiency, Child-Pugh grade C or Wuhan meeting grading standard III; 7. Severe renal insufficiency, GRF< 30mL/min/1.73m^2; 8. Known allergy to test-related drugs; 9. Patient's inborn metabolism of the nutrients contained in the products in this study; 10. Pregnant or lactating women; 11. Enrollment in other studies; 12. Other conditions judged by the investigator to be unsuitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Change of prealbumin from baseline at 14 days of enteral nutrition;

Secondary

MeasureTime frame
Albumin levels after 7 and 14 days of enteral nutrition;Feeding amount and tolerance;Disease severity score;Severity of infection;Mortality;

Countries

China

Contacts

Public ContactPan Jingye

The First Affiliated Hospital of Wenzhou Medical University

panjingye@wzhospital.cn+86 577 55578086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026