NCT07295301

Protein Intake Dosage on the Prognosis of Neurocritical Patients

A Clinical Applied Study on the Impact of Different Early Protein Supplementation Levels on the Prognosis of Neurocritical Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Wenshan City People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This single-center randomized trial enrolls neurocritical patients (e.g., severe brain injury, stroke) who have been in the ICU for ≥72 hours. Participants are randomly assigned to three groups with different early protein supplementation levels (1.0-1.2g/kg/d, 1.3-1.5g/kg/d, ≥1.6g/kg/d) for 14 days. The primary outcome is the 28-day Glasgow Coma Scale (GCS) score improvement rate (defined as GCS ≥13 or an absolute increase of ≥3 points from baseline). We also assess short-term (28-day mortality, ICU/hospital stay, ventilator-associated pneumonia) and long-term (90-day mortality, readmission rate, tracheostomy rate) clinical results. Data will be collected prospectively to find the optimal protein dose for neurocritical patients.

Conditions

• Neurocritical Conditions
• Traumatic Brain Injury
• Ischemic Stroke

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder)	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.
DIETARY_SUPPLEMENT	Moderate-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder)	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.
DIETARY_SUPPLEMENT	High-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder)	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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-06-01
• Completion: 2028-10-01
• First posted: 2025-12-19
• Last updated: 2025-12-19