The purpose of this academic lead study is to explore the ideal nutritional support strategy for patient with acute severe stroke.
Of high mortality and morbidity, severe stroke is associated with devastating damages in neurologic, respiratory, circulatory and many other systems. The outcomes of patients with severe stroke depend largely on medical strategies on acute stage, especially on nutritional support management. Unfortunately, clinical evidence are sparse and the ideal initial feeding strategy remains disputable. The IF-STROKE study aims to provide reliable data on the effects of modified full enteral feeding (target recruitment 200) and permissive underfeeding in patients with acute severe stroke (target recruitment 200) compared to full enteral feeding (target recruitment 200). Patients presenting with acute (\<72h) severe stroke (GCS ≦ 12 or NIHSS ≧ 11) and dysphagia (defined by Water Swallowing Test) will be randomly assigned to full enteral feeding, modified full enteral feeding, or permissive underfeeding treatment for 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
306
gastrointestinal (GI) motility improving
Xijing Hospital
Xi'an, Shaanxi, China
Tangdu Hospital
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University,
Xi'an, Shaanxi, China
Yulin No.2 Hospital
Yunlin, Shaanxi, China
Rate of patients with death or major disability (modified Rankin scale score ≥3)
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
Time frame: 3 months after enrollment
Mortality (rate of patients with death)
Rate of patients with death
Time frame: 3 months after enrollment
The scores of National Institute of Health stroke scale
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.
Time frame: 7 days after enrollment
Glasgow Coma Scale
Glasgow Coma Scale, with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.
Time frame: 7 days after enrollment
modified Rankin scale
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
Time frame: 7 days after enrollment
Barthel index
The Barthel Index is a scale, with score ranging from 0 to 100 (normal), that measures disability or dependence in activities of daily living in stroke patients
Time frame: 7 days after enrollment
modified Rankin scale
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
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Time frame: 3 months after enrollment
Barthel index
The Barthel Index is a scale, with score ranging from 0 to 100 (normal), that measures disability or dependence in activities of daily living in stroke patients
Time frame: 3 months after enrollment
The incidence of treatment intolerance
The intolerance including gastric retention, diarrhea, constipation, gastrointestinal hemorrhage
Time frame: 7 days after enrollment
The incidence of serious adverse events
Time frame: 3 months after enrollment
The incidence of adverse events That are related to treatment
Time frame: 3 months after enrollment