Intensive five day intravenous insulin treatment combined with enteral feeding in hyperglycemic ischemic stroke patients: a feasibility study
Phase 4
Withdrawn
- Conditions
- hyperglycemiahigh blood glucose10014523
- Registration Number
- NL-OMON31195
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1) Supratentorial stroke with a time of onset within 24h before presentation.
2) An acute neurological deficit measurable with the National Institute of Health Stroke Score (NIHSS, see appendix B) > 4 at presentation.
3) Venous plasma admission glucose > 7.0 mmol/l 5) Informed consent.
Exclusion Criteria
1) Signs of cerebral hemorrhage on computed tomography scan.
2) Previous history of diabetes mellitus and treatment with insulin.
3) Decreased consciousness (Glasgow Coma Scale < 8).
4) Patients in whom death appears imminent.
5) Patients under the age of 18
6) Pregnant patients
7) Patients admitted from a different coverage area.
8) When another patient is already included at that time.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Glucose profiles: area under the curve (AUC) > 6.1 mmol/l and AUC <4.4 mmol/l.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1) Time needed to perform all actions necessary for intensive insulin treatment.<br /><br>2) Adverse reactions<br /><br>a) Hypoglycemic episodes<br /><br>b) Incidence of aspiration pneumonia<br /><br>c) Infection or skin irritation at the site of tube insertion</p><br>