Optimizing Early Enteral Nutrition in Severe Stroke "OPENS"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Initial enteral feeding Other
    ARM 1: Kind: Experimental
    Label: Full enteral feeding
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Modified full enteral feeding
    Description: Consistent with full enteral feeding plan, preventively add erythromycin or mosapride everyday to improve gastrointestinal (GI) motility.
    ARM 3: Kind: Experimental
    Label: Permissive underfeeding
    Description: 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.
  • Erythromycin Drug
    Intervention Desc: gastrointestinal (GI) motility improving
    ARM 1: Kind: Experimental
    Label: Modified full enteral feeding
    Description: Consistent with full enteral feeding plan, preventively add erythromycin or mosapride everyday to improve gastrointestinal (GI) motility.

Outcomes

Type Measure Time Frame Safety Issue
Primary Death or major disability (defined by the modified Rankin scale) 3 months after onset
Secondary National Institute of Health stroke scale 14 days after onset
Secondary Symptomatic hypotension 7 days
Secondary Renal failure 7 days
Secondary Blood coagulation disorder 7 days
Secondary Adverse Events That Are Related to Treatment 7 days

Sponsors