Optimizing Early Nutrition Support in Severe Stroke-2 (NCT05998902) | Clinical Trial Compass
RecruitingPhase 3
Optimizing Early Nutrition Support in Severe Stroke-2
China546 participantsStarted 2023-12-20
Plain-language summary
Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke infections, in general, are associated with less favorable neurologic outcomes. Aspiration is one of the most feared complications of enteral nutrition and can lead to the occurrence of pneumonia. Severe stroke patients are at high risk for aspiration due to some factors such as the reduced level of consciousness, inability to protect the airway and so on. The purpose of this study is to explore the ideal nutrition support strategy for patient with acute severe stroke to help reduce the incidence of PSP and improve the prognosis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age≥18 years
✓. Definite diagnosis of acute stroke (GCS ≤12 or NIHSS≥11)
✓. The randomized nutritional treatment could be initiated up to 72 hours after symptom onset.
✓. Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.
✓. Plan to receive nutritional support treatment for at least 7 days.
✓. Informed consent.
Exclusion criteria
✕. Receiving parenteral nutrition support
✕. Contraindications of enteral nutrition
✕. Complicated with the disease which only have life expectancy \< 7 days
✕. Admission with infection signs
✕. Dementia or severe disability (mRS\>4) before stroke
✕. Presence of coexisting medical conditions that could interfere with outcome assessment and/or follow-up (a. advanced cancer; b. severe pulmonary dysfunction \[forced expiratory volume in 1 second \< 50% or/and moderate to severe acute lung injury (PaO2/FiO2)\<200mmHg\]; c. cardiac insufficiency (NYHA class \> I; cardiac structural and/or functional abnormalities such as EF\< 50%, abnormal cardiac chamber enlargement, moderate/severe ventricular hypertrophy, or moderate/severe valvular stenosis); d. Severe liver failure \[Child-Pugh score≥7\]; e. Severe renal failure \[glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL\]