Acute ischemic stroke after successful endovascular therapy in patients with known diabetes mellitus or admission hyperglycemia
Conditions
Interventions
Group 1: Intensive glucose target range 100–139 mg/dL: For 24 hours after randomization, structured intravenous glucose management is performed using a human insulin infusion according to a standardiz
Sponsors
Universitätsklinikum Heidelberg, Neurologische Klinik
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Acute ischemic stroke. • Successful endovascular therapy with an angiographic reperfusion result of TICI 2c or 3. • Known diabetes mellitus or blood glucose level >140 mg/dL at admission. • Admission to a monitored ward where the study-specific glucose management, including the scheduled point-of-care or blood gas glucose measurements and documentation, can be performed safely. • Informed consent provided by the patient or, in case of lacking capacity to consent, inclusion according to the representative or deferred-consent procedure specified in the study protocol.
Exclusion criteria
Exclusion criteria: • Angiographic reperfusion result TICI =2b. • Known or previously documented severe recurrent hypoglycemia. • Blood glucose level >299 mg/dL at admission or suspected diabetic ketoacidosis or hyperosmolar hyperglycemic state. • Palliative treatment situation or treatment limitation incompatible with the study intervention. • Known pregnancy; no study-specific pregnancy testing is planned. • Participation in another interventional study if it conflicts with the glucose management protocol. • Inability to perform the study intervention safely for organizational or clinical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the proportion of participants who achieve a time in range of at least 70% within their assigned glucose target range during the 24-hour intervention period. Time in range is defined as the percentage of all protocol-scheduled blood glucose measurements obtained by blood gas analysis or point-of-care testing that fall within the assigned target range. It is assessed during the first 24 hours after successful reperfusion and randomization. This is a measurement-based rather than a continuous-glucose-monitoring-based time in range. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: rates of hypoglycemia 200 mg/dL, and glucose values outside the safe range of 70–200 mg/dL during the 24-hour intervention, assessed by blood gas analysis or point-of-care testing; change in the National Institutes of Health Stroke Scale score from admission to 24 and 72 hours; hemorrhagic transformation according to the Heidelberg classification and other complications during hospitalization; protocol adherence during the 24-hour intervention, assessed by completeness of scheduled measurements, correct application of the algorithm, and completeness of documentation; exploratory functional outcome at 90 ± 7 days, assessed by the modified Rankin Scale in a standardized telephone interview; and acceptance and practical feasibility among nursing and medical staff, assessed during the study using an anonymous standardized questionnaire. | — |
Countries
Germany
Contacts
Public ContactAlexandra Filipov
Universitätsklinikum Heidelberg, Neurologische Klinik
Outcome results
None listed