Stroke Clinical Trial
— GlyENStrokeOfficial title:
Influence of Two Enteral Nutrition Formulas on Hyperglycemia and Morbidity in Patients With Stroke
The purpose of this study is to evaluate the effect of a specific nutritional formula for diabetics on the development of hyperglycemia in patients with recent non-diabetic stroke who require admission and enteral nutritional support by nasogastric tube. As well as the effect on metabolic control, development of comorbidities, hospital stay, readmissions, mortality and tolerance of the formula under study.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 15, 2020 |
Est. primary completion date | June 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Admitted for a first episode of ischemic or hemorrhagic stroke. - Requiring total enteral nutrition by tube for at least 7 days Exclusion Criteria: - Contraindication to enteral nutrition - Diabetes Mellitus - Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting, abdominal pain - Need for admission to the ICU - Previous neurodegenerative disease - Antibiotherapy for 7 days prior to the inclusion visit - Allergies or intolerances to any of the components of the formula under study - Pregnant patients |
Country | Name | City | State |
---|---|---|---|
Spain | Clinic Universitary Hospital | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Endocrinology and Clinical Nutrition Research Center, Spain |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HYPERGLUCEMIA POST-ENTERAL NUTRITION | Glycemia over 150 mg / dl after the beginning of infusion of complete enteral. nutrition determined by capillary glycemia during admission. Dicotomic variable (Yes/No) | 2 WEEKS | |
Secondary | MORTALITY | Mortality during study period. Dicotomic variable (Yes/No) | 3 months | |
Secondary | ORAL FEEDING RECOVERY | Recovery of oral feeding (More than 75% of energy needs) and withdrawal of nasogastric tube during admission. Dicotomic variable (Yes/No) | 3 months |
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