Optimizing Early Nutrition Support in Severe Stroke-2
- Conditions
- DysphagiaAcute StrokeSevere Stroke
- Interventions
- Procedure: Full enteral feedingProcedure: Trophic enteral feeding combined with supplemental parenteral nutrition
- Registration Number
- NCT05998902
- Lead Sponsor
- Wen Jiang-3
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 546
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Full enteral feeding Full enteral feeding Patients will receive full enteral feeding through nasogastric tube or nasointestinal tube. Trophic enteral feeding combined with supplemental parenteral nutrition Trophic enteral feeding combined with supplemental parenteral nutrition Patients will receive trophic enteral feeding combined with supplemental parenteral feeding.
- Primary Outcome Measures
Name Time Method Incidence of post stroke pneumonia up to 7 days
- Secondary Outcome Measures
Name Time Method Daily calorie delivery up to 7 days The use of vasoactive agents 1 day of ICU discharge The usage rate of vasoactive agents from randomisation to ICU discharge
The score of National Institute of Health stroke scale at ICU discharge 1 day of ICU discharge National Institute of Health stroke scale, with scores ranging from 0 (normal function) to 42 (functional impairment) was used to evaluate the impairment caused by a stroke.
Glasgow Coma Scale at ICU discharge 1 day of ICU discharge Glasgow Coma Scale,with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.
The time from randomisation to the onset of the post stroke pneumonia up to 7 days Daily protein delivery up to 7 days The use of prokinetic agents up to 7 days The usage rate of prokinetic agents
The length of ICU stay 1 day of ICU discharge Mortality 1 day of ICU discharge from randomisation to all cause death during ICU stay.
Insulin dosage up to 7 days The incidence of gastrointestinal complications up to 7 days Vomiting, diarrhea, gastric retention, gastrointestinal bleeding
Mechanical ventilation 1 day of ICU discharge The incidence of mechanical ventilation from randomisation to ICU discharge
Deep venous thrombosis 1 day of ICU discharge The incidence of deep venous thrombosis from randomisation to ICU discharge
modified Rankin scale at ICU discharge 1 day of ICU discharge modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
The occurrence of infections 1 day of ICU discharge The rate and onset time of infections from randomisation to ICU discharge
The All-cause mortality rate 28 days after enrollment from randomisation to all cause death at 28 days
Cardiac failure 1 day of ICU discharge The incidence of cardiac failure from randomisation to ICU discharge
Tracheotomy 1 day of ICU discharge The incidence of tracheotomy from randomisation to ICU discharge
Continuous renal replacement therapy 1 day of ICU discharge The incidence of continuous renal replacement therapy from randomisation to ICU discharge
modified Rankin scale 90 days after enrollment modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
Trial Locations
- Locations (20)
Daping Hospital, The Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Gansu Provincal Central Hospital
🇨🇳Lanzhou, Gansu, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
The First Hospital of Changsha City
🇨🇳Changsha, Hunan, China
Tangdu Hospital
🇨🇳Xi'an, Shaanxi, China
Xi'an Central Hospital
🇨🇳Xi'an, Shaanxi, China
Department of Neurology, Xijing Hospital
🇨🇳Xi'an, Shaanxi, China
Shannxi Provincal People's Hospital
🇨🇳Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Medical University
🇨🇳Xi'an, Shaanxi, China
Xi'an Gaoxin Hospital
🇨🇳Xi'an, Shaanxi, China
Xi'an No.3 Hospital
🇨🇳Xi'an, Shaanxi, China
The First People's Hospital of Xianyang
🇨🇳Xianyang, Shaanxi, China
Yulin No.1 Hospital
🇨🇳Yulin, Shaanxi, China
Yulin No.2 Hospital
🇨🇳Yulin, Shaanxi, China
Qilu Hospital of Shangdong University
🇨🇳Jinan, Shandong, China
The PLA 960 Hospital
🇨🇳Jinan, Shandong, China
The Second Hospital of Shandong University
🇨🇳Jinan, Shandong, China