Optimizing Early Nutrition Support in Severe Stroke-2

Wen Jiang-3

Status and phase: Enrolling; Phase 3

Conditions: Severe Stroke; Dysphagia; Acute Stroke

Treatments: Procedure: Full enteral feeding; Procedure: Trophic enteral feeding combined with supplemental parenteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT05998902

XJLL-KY-20222214

Details and patient eligibility

About

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.

Full description

As one of the most common complication of stroke, some studies showed that post-stroke pneumonia (PSP) in stroke patients requiring intensive care is associated with an increase of ICU length of stay and hospital mortality and poorer functional outcomes in survivors. The peak period of PSP is within the first week after stroke. Aspiration and poor nutritional status are important factors leading to pneumonia in stroke patients. Compared with full enteral nutrition (EN), initial trophic enteral feeding was associated with less gastrointestinal intolerance and could reduce the rate of regurgitation. However, trophic enteral feeding could not meet the daily caloric needs and hypocaloric enteral nutrition might be associated with increased mortality. This study is designed to explore whether initial trophic enteral nutrition combined with supplemental parenteral nutrition (SPN) can help reduce the incidence of PSP and improve the prognosis in severe patients with stroke.

This study will enroll 546 severe stroke patients who meet the inclusion criteria. Upon admission to the ICU, patients will be randomly assigned at a 1:1 ratio into groups of full enteral feeding (controlled) and trophic enteral feeding combined with supplemental parenteral feeding (experimented) for 7 days.

Enrollment: 546 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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546 participants in 2 patient groups

Full enteral feeding

Active Comparator group

Description:

Patients will receive full enteral feeding through nasogastric tube or nasointestinal tube.

Treatment:

Procedure: Full enteral feeding

Trophic enteral feeding combined with supplemental parenteral nutrition

Experimental group

Description:

Patients will receive trophic enteral feeding combined with supplemental parenteral feeding.

Treatment:

Procedure: Trophic enteral feeding combined with supplemental parenteral nutrition