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
- Betegségek
- Stroke (szélütés)
- 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
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