Clinical trial NCT05998902: Optimizing Early Nutrition Support in Severe Stroke-2
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Severe Stroke
Acute Stroke
Dysphagia
Keywords: Severe Stroke
Acute Stroke
Dysphagia
supplemental parenteral nutrition
trophic feeding
pneumonia
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Tang-Du Hospital
name: Xi'an Central Hospital
name: Xi'an Gaoxin Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Xi'an No.3 Hospital
name: First People's Hospital of Xianyang
name: Nanfang Hospital, Southern Medical University
name: Tongji Hospital
name: Qilu Hospital of Shandong University
name: The Second Hospital of Shandong University
name: PLA 960 Hospital
name: Daping Hospital, The Third Military Medical University (Army Medical University)
name: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
name: First Hospital Affiliated to Zhengzhou University
name: Gansu Provincial Central Hospital
name: The First Hospital of Changsha City
name: Shaanxi Provincial People's Hospital
name: Yulin No.2 Hospital
name: Yulin No.1 Hospital
name: Xijing Hospital
First posted: 2023-08-21
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Incidence of post stroke pneumonia
timeFrame: up to 7 days
Secondary outcomes:
measure: The time from randomisation to the onset of the post stroke pneumonia
timeFrame: up to 7 days
measure: Daily calorie delivery
timeFrame: up to 7 days
measure: Daily protein delivery
timeFrame: up to 7 days
measure: Insulin dosage
timeFrame: up to 7 days
measure: The incidence of gastrointestinal complications
timeFrame: up to 7 days
measure: The use of prokinetic agents
timeFrame: up to 7 days
measure: The occurrence of infections
timeFrame: 1 day of ICU discharge
measure: The length of ICU stay
timeFrame: 1 day of ICU discharge
measure: Mortality
timeFrame: 1 day of ICU discharge
measure: The All-cause mortality rate
timeFrame: 28 days after enrollment
measure: Cardiac failure
timeFrame: 1 day of ICU discharge
measure: Tracheotomy
timeFrame: 1 day of ICU discharge
measure: Mechanical ventilation
timeFrame: 1 day of ICU discharge
measure: Continuous renal replacement therapy
timeFrame: 1 day of ICU discharge
measure: The use of vasoactive agents
timeFrame: 1 day of ICU discharge
measure: Deep venous thrombosis
timeFrame: 1 day of ICU discharge
measure: The score of National Institute of Health stroke scale at ICU discharge
timeFrame: 1 day of ICU discharge
measure: Glasgow Coma Scale at ICU discharge
timeFrame: 1 day of ICU discharge
measure: modified Rankin scale at ICU discharge
timeFrame: 1 day of ICU discharge
measure: modified Rankin scale
timeFrame: 90 days after enrollment
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
state: Chongqing
city: Chongqing
country: China
facility: Daping Hospital, The Third Military Medical University
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Provincal Central Hospital
state: Gansu
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Changsha
country: China
facility: The First Hospital of Changsha City
state: Hunan
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: Shaanxi Second Provincal People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The first affiliated hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Department of Neurology, Xijing Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Shannxi Provincal People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Gaoxin Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an No.3 Hospital
state: Shaanxi
city: Xianyang
country: China
facility: Xianyang Hospital, Yan'an University
state: Shaanxi
city: Xianyang
country: China
facility: The First People's Hospital of Xianyang
state: Shaanxi
city: Yulin
country: China
facility: Yulin No.1 Hospital
state: Shaanxi
city: Yulin
country: China
facility: Yulin No.2 Hospital
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shangdong University
state: Shandong
city: Jinan
country: China
facility: The PLA 960 Hospital
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Urumqi
country: China
facility: The Second Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
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