Optimizing Early Enteral Nutrition in Severe Stroke
- Conditions
- Severe StrokeAcute StrokeDysphagia
- Interventions
- Other: Initial enteral feeding
- Registration Number
- NCT02982668
- Lead Sponsor
- Xijing Hospital
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 306
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Full enteral feeding Initial enteral feeding 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. Modified full enteral feeding Initial enteral feeding Consistent with full enteral feeding plan, preventively add metoclopramide or mosapride everyday to improve gastrointestinal (GI) motility. Modified full enteral feeding metoclopramide or mosapride Consistent with full enteral feeding plan, preventively add metoclopramide or mosapride everyday to improve gastrointestinal (GI) motility. Permissive underfeeding Initial enteral feeding The caloric goal of the first day is one-third of caloric requirements, the second day is 40-60% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Mortality (rate of patients with death) 3 months after enrollment Rate of patients with death
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 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.
Barthel index 3 months 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
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
Trial Locations
- Locations (4)
Xijing Hospital
🇨🇳Xi'an, Shaanxi, China
Tangdu Hospital
🇨🇳Xi'an, Shaanxi, China
Yulin No.2 Hospital
🇨🇳Yunlin, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University,
🇨🇳Xi'an, Shaanxi, China