cerebral infarction glucose control stroke
Conditions
Interventions
continuous tube feeding (vs. regular feeding)
Vildagliptin (vs. placebo)
IV insulin (all patients)
continuous glucose measurement (all patients)
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Supra-tentorial 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 I) >= 4 at presentation. 3) Venous plasma admission glucose > 7.0 mmol/l 4) Informed consent.
Exclusion criteria
Exclusion criteria: 1) Signs of cerebral hemorrhage on computed tomography scan 2) Previous history of diabetes mellitus treated with insulin 3) Patients in whom death appears imminent 4) Renal insufficiency defined as creatinine > 150 mmol/L 5) Patients under the age of 18 6) Pregnant patients 7) Expected transfer to a different hospital within 5 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study has two primary endpoints • 1) Glycemic control. a) Mean glucose throughout protocol treatment b) Percentage of time spent within target range. • 2) Hypoglycemia a) The total number of hypoglycemic events per group. Hypoglycemia will be defined as any glucose value below 3.5 mmol/L. b) Number of of serious hypoglycemic events (glucose value below 2.2 mmol/L) c) Number of symptomatic confirmed events. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Clinical outcome: o Modified Rankin Score at three months follow-up (see appendix IV). • Occurrence of pneumonia • Treatment data: o Total insulin dose U/dy en U/kg/dy o Total amount of tube feeding administered o Number of sensors inserted per patient o Coefficient of Variation of CGMS derived glucose values o Accuracy of FreeStyle Navigator, expressed as Mean Absolute Difference vs. verification samples | — |
Countries
Netherlands
Outcome results
None listed