Optimizing Early Nutrition Support in Severe Stroke-2

Launched by WEN JIANG-3 · Aug 11, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Optimizing Early Nutrition Support in Severe Stroke-2," is looking at how to provide the best nutritional support for patients who have experienced a severe stroke. After a stroke, many patients can develop pneumonia, especially if they have difficulty swallowing or protecting their airway. The goal of this study is to find the most effective way to support these patients with nutrition, which may help lower the risk of pneumonia and improve their recovery outcomes.

To participate in this trial, you must be at least 18 years old and have been diagnosed with an acute stroke, with certain severity levels. You would need to start the nutritional treatment within 72 hours of your stroke symptoms. The study is currently recruiting participants, regardless of gender. If you join, you can expect to receive specialized nutritional care for at least a week while the research team monitors your health. It's important to know that some patients may not be eligible due to specific health conditions or treatments they are currently receiving.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age≥18 years
• • 2. Definite diagnosis of acute stroke (GCS ≤12 or NIHSS≥11)
• • 3. The randomized nutritional treatment could be initiated up to 72 hours after symptom onset.
• • 4. Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.
• • 5. Plan to receive nutritional support treatment for at least 7 days.
• • 6. Informed consent.
• Exclusion Criteria:
• • 1. Receiving parenteral nutrition support
• • 2. Contraindications of enteral nutrition
• • 3. Complicated with the disease which only have life expectancy \< 7 days
• • 4. Admission with infection signs
• • 5. Dementia or severe disability (mRS\>4) before stroke
• • 6. Antibiotics were used within the previous 7 days
• • 7. Subarachnoid hemorrhage, cerebral arteriovenous malformation
• • 8. 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 \[glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL\]
• • 9. Currently participating in other clinical trial
• • 10. Pregnant woman
• • 11. Patient who is considered highly likely not to adhere to the study treatment or follow-up protocol.