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NCT07295301Toborzás még nem indult

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 19.

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
216 (tervezett)
Első benyújtás
2025. dec. 7.
Kezdés
2025. dec.
Elsődleges befejezés
2028. jún.
Fő szponzor
Wenshan City People's Hospital
NCT-szám
NCT07295301

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 216
  • 2025. dec. és az elsődleges befejezés (2028. jún.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Laborértékek

  • 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.

Kiket keres a vizsgálat

  • 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).

Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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