Optimizing Early Enteral Nutrition in Severe Stroke

Study Overview
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Brief Summary
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The purpose of this academic lead study is to explore the ideal nutritional support strategy for patient with acute severe stroke.

Detailed Description
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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.

Official Title
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A Multi-center Randomised Controlled Trial to Explore the Ideal Initial Enteral Feeding Strategies in Patients With Severe Stroke at Acute Stage

Conditions
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Severe Stroke, Acute Stroke, Dysphagia

Intervention / Treatment
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* Other: Initial enteral feeding
* Drug: metoclopramide or mosapride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Full enteral feeding<br>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. | Other: Initial enteral feeding<br> <br> |
| Experimental: Modified full enteral feeding<br>Consistent with full enteral feeding plan, preventively add metoclopramide or mosapride everyday to improve gastrointestinal (GI) motility. | Other: Initial enteral feeding<br> <br> Drug: metoclopramide or mosapride<br>* gastrointestinal (GI) motility improving<br>|
| Experimental: Permissive underfeeding<br>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. | Other: Initial enteral feeding<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality (rate of patients with death) | Rate of patients with death | 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. | 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. | 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. | 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 | 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. | 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 | 3 months after enrollment | 
| The incidence of treatment intolerance | The intolerance including gastric retention, diarrhea, constipation, gastrointestinal hemorrhage | 7 days after enrollment | 
| The incidence of serious adverse events |  | 3 months after enrollment | 
| The incidence of adverse events That are related to treatment |  | 3 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe stroke, Acute Stroke, Enteral Feeding, Mortality, Disability, Clinical trial