Optimizing Early Nutrition Support in Severe Stroke-2

Phase 3RecruitingNCT05998902

Wen Jiang-3546 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Interventions

Trophic enteral feeding combined with supplemental parenteral nutritionPROCEDURE

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.

Full enteral feedingPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (30)

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Gansu Provincal Central Hospital

Lanzhou, Gansu, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Incidence of post stroke pneumonia

Time frame: up to 7 days

Secondary Outcomes

The time from randomisation to the onset of the post stroke pneumonia

Time frame: up to 7 days

Daily calorie delivery

Time frame: up to 7 days

Daily protein delivery

Time frame: up to 7 days

Insulin utilization

Insulin utilization during the first 7 days post-randomization

Time frame: up to 7 days

The incidence of gastrointestinal complications

Vomiting, diarrhea, gastric retention, gastrointestinal bleeding

Time frame: up to 7 days

The use of prokinetic agents

The usage rate of prokinetic agents

Time frame: up to 7 days

The occurrence of infections

The rate and onset time of infections from randomisation to ICU discharge