No registrations found.
ID
Source
Brief title
Health condition
acute ischemic stroke; hyperglycemia; acuut herseninfarct; hyperglycemie.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Glycemic control. (Mean glucose throughout protocol treatment; Percentage of time spent within target range);
2. Hypoglycemia (glucose <3.5 mmol/L): Number of hypoglycemic events per group, Number of serious hypoglycemic events (glucose<2.2 mmol/L), Number of symptomatic confirmed hypoglycemic events.
Secondary outcome
1. Clinical outcome (modified Rankin score) at three months;
2. Incidence of pneumonia;
3. Treatment data.
Background summary
Hyperglycemia has been associated with poor clincal outcome in patients with acute ischemic stroke. Therefore, glycemic control has the potential to improve clinical outcome. Glycemic control, however, appears to be difficult to establish due to postprandial glucose surges and an increased number of hypoglycemic episodes. With this study we investigate if (i) glycemic control in continuous tube fed patients is superior compared to regularly fed patients and (ii) If vildagliptin as add-on therapy to insulin results in less hypoglycemic episodes compared to placebo.
Study objective
1. TGC with insulin in continuous tube fed patients is superior to TGC with insulin in regularly fed patients;
2. Vildagliptin as add-on therapy to insulin mediated TGC results in less hypoglycemic episodes compared to placebo.
Study design
1. 5 days;
2. 3 months.
Intervention
1. IV insulin;
2. Continuous tube feeding;
3. Vildagliptin.
University of Amsterdam
P.O. Box 22700
Nyika Kruyt
Department of Neurology
H2-218
Academic Medical Center
University of Amsterdam
Amsterdam 1100 DE
The Netherlands
+31 20 566 3547
n.d.kruijt@amc.uva.nl
University of Amsterdam
P.O. Box 22700
Nyika Kruyt
Department of Neurology
H2-218
Academic Medical Center
University of Amsterdam
Amsterdam 1100 DE
The Netherlands
+31 20 566 3547
n.d.kruijt@amc.uva.nl
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 (see appendix I, NIHSS score) ¡Ý 4 at presentation;
3. Venous plasma admission glucose > 7.0 mmol/l;
4. Informed consent.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1764 |
| NTR-old | NTR1874 |
| Other | METC AMC : 08/382 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |