Protein Intake Dosage on the Prognosis of Neurocritical Patients

Sponsor
Wenshan City People's Hospital
Study ID
NCT07295301
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder) — DIETARY_SUPPLEMENT
    This intervention provides enteral protein supplementation for neurocritical patients in the ICU, using enteral nutrition formulas (in powder or emulsion form). When the protein dosage of the enteral nutrition formula is insufficient, whey protein powder is added; intravenous amino acids are used as an alternative only when patients refuse whey protein powder supplementation. The intervention is initiated within 48 hours of ICU admission, with the protein dosage adjusted gradually: 0.2-0.8 g/kg/d from day 1 to day 4, 0.8-1.0 g/kg/d from day 5 to day 7, and then maintained at 1.0-1.2 g/kg/d from day 8 to day 14. It is administered daily via oral intake or tube feeding.
  • Moderate-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder) — DIETARY_SUPPLEMENT
    Enteral protein supplementation for neurocritical patients in the ICU, using enteral nutrition formulas (including powders or emulsions). Whey protein powder is added when the protein dosage of the enteral nutrition formula is insufficient. Initiated within 48 hours of ICU admission, with dosage adjusted gradually: 0.2-0.8 g/kg/d from day 1 to day 4, 0.8-1.0 g/kg/d from day 5 to day 7, and then maintained at 1.3-1.5 g/kg/d from day 8 to day 14. Administered via oral intake or tube feeding, daily.
  • High-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder) — DIETARY_SUPPLEMENT
    Enteral protein supplementation for neurocritical patients in the ICU, using enteral nutrition formulas (including powders or emulsions). Whey protein powder is added when the protein dosage of the enteral nutrition formula is insufficient. Initiated within 48 hours of ICU admission, with dosage adjusted gradually: 0.2-0.8 g/kg/d from day 1 to day 4, 0.8-1.0 g/kg/d from day 5 to day 7, and then maintained at above 1.6 g/kg/d from day 8 to day 14. Administered via oral intake or tube feeding, daily.

Study Details

This study investigates the effect of different early protein supplementation levels (1.0-2.0g/kg/d, divided into three groups) on the prognosis of neurocritical patients, focusing on the 28-day Glasgow Coma Scale (GCS) score improvement rate. Participants will be randomly assigned to receive varying protein doses, and their short-term (28-day mortality, ICU stay, complications) and long-term (90-day mortality, readmission rate) clinical outcomes will also be compared.

Key Dates

First listed
Dec 19, 2025
Start date
Dec 31, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low-Dose Protein Supplementation Group (1.0-1.2 g/kg/d)
    Enteral nutrition is initiated within 48 hours of ICU admission. From day 1 to day 4, protein dosage is 0.2-0.8 g/kg/d, energy is 5-10 kcal/kg/d. From day 5 to day 7, dosage is gradually increased, with protein dosage 0.8-1.0 g/kg/d, energy 15-20 kcal/kg/d. From day 8 to day 14, participants receive protein supplementation at 1.0-1.2 g/kg/d via enteral nutrition. Observation period lasts 14 days.
  • Experimental: Moderate-Dose Protein Supplementation Group (1.3-1.5 g/kg/d)
    Enteral nutrition is initiated within 48 hours of ICU admission. From day 1 to day 4, protein dosage is 0.2-0.8 g/kg/d, energy is 5-10 kcal/kg/d. From day 5 to day 7, dosage is gradually increased, with protein dosage 0.8-1.0 g/kg/d, energy 15-20 kcal/kg/d. From day 8 to day 14, participants receive protein supplementation at 1.3-1.5 g/kg/d via enteral nutrition. Observation period lasts 14 days.
  • Experimental: High-Dose Protein Supplementation Group (Above 1.6 g/kg/d)
    Enteral nutrition is initiated within 48 hours of ICU admission. From day 1 to day 4, protein dosage is 0.2-0.8 g/kg/d, energy is 5-10 kcal/kg/d. From day 5 to day 7, dosage is gradually increased, with protein dosage 0.8-1.0 g/kg/d, energy 15-20 kcal/kg/d. From day 8 to day 14, participants receive protein supplementation at above 1.6 g/kg/d via enteral nutrition. Observation period lasts 14 days.

Primary Outcome Measure

Improvement Rate of Glasgow Coma Scale (GCS) Score at 28 Days [ Time Frame: 28 days ]

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