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NCT Number: NCT07295301

Protein Intake Dosage on the Prognosis of Neurocritical Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Improvement Rate of Glasgow Coma Scale (GCS) Score at 28 Days

    Time frame: 28 days

    Assesses the proportion of ICU neurocritical patients with significant consciousness improvement at 28 days, defined as GCS score ≥13. Baseline GCS (T0) is measured on the enrollment day after vital signs stabilize (e.g., ICP ≤25mmHg, no persistent seizures). The 28-day GCS (T28) is evaluated within 28±3 days: in-hospital patients are scored by neurologists; discharged patients are scored via outpatient visit or structured telephone interview with family. Patients who die within 28 days or have GCS <13 / GCS increase <3 are defined as "not improved".

Secondary outcomes

  1. 28-Day Mortality

    Time frame: 28 days

    Assesses the proportion of ICU neurocritical patients who die within 28 days after enrollment. Death events are confirmed via medical records and follow-up interviews.

Other outcomes

  1. Duration of Mechanical Ventilation

    Time frame: Up to 28 days

    Records the total days of mechanical ventilation (invasive/non-invasive) from initiation to discontinuation in ICU neurocritical patients. Data is extracted from ventilator usage and nursing records.

  2. ncidence of Infection

    Time frame: 14 days

    Evaluates the proportion of ICU neurocritical patients developing new infections (e.g., pneumonia, bloodstream infection) within 28 days, diagnosed via clinical symptoms, laboratory tests, and imaging.

  3. Change in Serum Albumin Level

    Time frame: Baseline and 14 days

    Measures the difference in serum albumin concentration from baseline (enrollment day) to 14 days, reflecting nutritional status. Blood samples are tested in the laboratory.

  4. 90-Day Mortality

    Time frame: 90 days

    Assesses the proportion of ICU neurocritical patients who die within 90 days after enrollment. Data is collected via medical records, community follow-up, and family telephone interviews.

  5. 90-Day Readmission Rate

    Time frame: 90 days

    Evaluates the proportion of ICU neurocritical patients readmitted to the hospital within 90 days after discharge, due to conditions related to the original neurological critical illness or complications. Data is extracted from hospital admission management systems.

Sponsors and collaborators

Lead sponsor

Wenshan City People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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