Optimizing Early Nutrition Support in Severe Stroke-2
Trophic Enteral Feeding Combined With Supplemental Parenteral Nutrition Treatment in Patients With Severe Stroke (OPENS-2): a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial
Wen Jiang-3
546 participants
Dec 20, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria11
- 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
- Antibiotics were used within the previous 7 days
- Subarachnoid hemorrhage, cerebral arteriovenous malformation
- 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 \[glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL\]
- Currently participating in other clinical trial
- Pregnant woman
- Patient who is considered highly likely not to adhere to the study treatment or follow-up protocol.
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Interventions
The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Patients will receive the trophic enteral feeding with a caloric target of 500kcal/d (20-35ml/h), and the remaining calories are supplemented by parenteral nutrition. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.
The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day. Enteral nutrition is given through nasogastric tube or nasointestinal tube.
Locations(30)
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NCT05998902