Protein Intake Dosage on the Prognosis of Neurocritical Patients

Wenshan City People's Hospital

Status: Not yet enrolling

Conditions: Neurocritical Conditions; Ischemic Stroke; Traumatic Brain Injury

Treatments: Dietary Supplement: Low-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder); Dietary Supplement: Moderate-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder); Dietary Supplement: High-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder)

Study type: Interventional

Funder types: Other

Identifiers

NCT07295301

2025AE003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion Criteria:

Age: 18-80 years old. Disease Diagnosis and Hospitalization: Meets any neurocritical disease diagnosis and requires admission to the neurosurgical ICU for ≥72 hours (based on 2022 Consensus on Chinese Neurosurgical Critical Care).

Disease Type (Meet criteria for any one disease):

Severe Acute Ischemic Stroke (AIS): Diagnosed with acute ischemic stroke (sudden neurological deficit like hemiplegia, aphasia, confirmed by CT/MRI) and severe criteria (NIHSS ≥16, large vessel occlusion in internal carotid artery terminal, MCA M1 segment or basilar artery, or ischemic lesion involving >1/3 cerebral hemisphere).

Severe Spontaneous Intracerebral Hemorrhage (ICH): Diagnosed with spontaneous ICH (sudden headache/vomiting/neurological deficit, confirmed by CT) and severe criteria (supratentorial hemorrhage ≥30ml / infratentorial hemorrhage ≥10ml, hemorrhage involving brainstem/diencephalon, or GCS ≤8).

Severe Traumatic Brain Injury (TBI): Diagnosed with TBI (trauma history, CT showing intracranial hematoma/brain contusion/diffuse axonal injury) and severe criteria (GCS 3-8 within 6 hours post-injury, intracranial hematoma ≥20ml (epidural ≥30ml / subdural ≥10ml), or combined brainstem injury).

General Neurocritical Inclusion (Meet at least 1):

Altered consciousness: GCS ≤8 (severe consciousness disorder) or progressive deterioration of consciousness within 24 hours before enrollment (e.g., somnolence→stupor→coma).

Respiratory/circulatory instability: Require non-invasive (BiPAP) or invasive mechanical ventilation, or vasoactive drugs (norepinephrine ≥0.1μg/kg/min) to maintain systolic blood pressure ≥90mmHg, or central respiratory rhythm abnormalities (e.g., Cheyne-Stokes respiration, apnea).

Increased intracranial pressure (ICP): Invasive ICP monitoring shows sustained ICP >25mmHg, or CT/MRI suggests pre-herniation signs (ventricular compression, midline shift >5mm, sulcal effacement).

Severe neurological deficit: Quadriplegia (muscle strength ≤2), swallowing disorder (Watada drinking test ≥IV, high risk of aspiration), status epilepticus (seizure >5 minutes or recurrent seizures >30 minutes without consciousness recovery).

Nutritional Support Timing: Initiate enteral nutrition (EN) within 24-48 hours after ICU admission, and expect EN to last ≥5 days.

Nutritional Risk: NUTRIC score ≥5 (high nutritional risk) or NRS-2002 score ≥3. Informed Consent: Signed by the patient or legal guardian (signed by guardian for comatose patients, confirmed by the patient after condition improvement).

Exclusion criteria

• Terminal Diseases: Diagnosed with advanced malignant tumor (life expectancy <3 months), irreversible vegetative state (persistent ≥1 month), or long-term renal replacement therapy (RRT) planned to last >2 weeks before enrollment.

Gastrointestinal Contraindications: Complete intestinal obstruction, massive gastrointestinal bleeding within 24 hours (blood transfusion ≥4U), severe intestinal ischemia, short bowel syndrome (remaining small intestine <100cm).

Metabolic Abnormalities: Congenital urea cycle disorder, severe liver failure (Child-Pugh Class C), allergy to the study's enteral nutrition formula (whey protein/short peptide type), uncontrolled diabetes (fasting blood glucose sustained >13.9mmol/L).

Others: Participating in other clinical studies on nutritional intervention, or patient/family refuses to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 3 patient groups

Low-Dose Protein Supplementation Group (1.0-1.2 g/kg/d)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Low-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder)

Moderate-Dose Protein Supplementation Group (1.3-1.5 g/kg/d)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Moderate-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder)

High-Dose Protein Supplementation Group (Above 1.6 g/kg/d)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: High-Dose Enteral Protein Supplementation (Enteral Nutrition Formulas + Whey Protein Powder)