Acute Stroke, Dysphagia, Severe Stroke
Conditions
Keywords
severe stroke, Acute Stroke, Enteral Feeding, Mortality, Disability, Clinical trial
Brief summary
The purpose of this academic lead study is to explore the ideal nutritional support strategy for patient with acute severe stroke.
Detailed description
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.
Interventions
OTHERInitial enteral feeding
DRUGmetoclopramide or mosapride
gastrointestinal (GI) motility improving
Sponsors
Tang-Du Hospital
Xi'an Central Hospital
Xi'an Gaoxin Hospital
Yan'an University Affiliated Hospital
940 Hospital of the People's Liberation Army Joint Logistic Support Force
Xi'an No.3 Hospital
First Affiliated Hospital Xi'an Jiaotong University
Yulin No.1 Hospital
First People's Hospital of Xianyang
Tongchuan Mining Hospital
The PLA General Hospital of Xinjiang
Tongchuan People's Hospital
Yulin No.2 Hospital
Ankang Central Hospital
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe stroke occurred in 7 days. * GCS ≤12 or NIHSS≥11. * Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness. * Plan to receive enteral feeding for at least 7 days. * Informed consent.
Exclusion criteria
* Gastrointestinal diseases before stroke, such as gastrointestinal resection, malabsorption,and irritable bowel syndrome. * Brain death. * Complicated with the disease which only have life expectancy \< 6 months in over 50% patients. * After cardiac arrest. * Received parenteral nutrition support. * Pregnant woman. * Concurrent severe hepatic or renal dysfunction。 * Unstable hemodynamics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with death or major disability (modified Rankin scale score ≥3) | 3 months after enrollment | modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The scores of National Institute of Health stroke scale | 7 days after enrollment | 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 | 7 days after enrollment | Glasgow Coma Scale, with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state. |
| modified Rankin scale | 7 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. |
| Mortality (rate of patients with death) | 3 months after enrollment | Rate of patients with death |
| The incidence of treatment intolerance | 7 days after enrollment | The intolerance including gastric retention, diarrhea, constipation, gastrointestinal hemorrhage |
| The incidence of serious adverse events | 3 months after enrollment | — |
| The incidence of adverse events That are related to treatment | 3 months after enrollment | — |
| Barthel index | 7 days after enrollment | 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 |
Countries
China
Outcome results
None listed