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This study is a exploratory, randomized, controlled, open-label, blinded-endpoint Phase II clinical trial designed to evaluate whether delaying antihyperglycemic treatment for 72 hours improves neurological outcomes in patients with severe stroke and hyperglycemia.
A total of 426 patients with severe stroke (including ischemic stroke, intracerebral hemorrhage, or aneurysmal subarachnoid hemorrhage) within 24 hours of onset and blood glucose >10 mmol/L at randomization will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either delayed antihyperglycemic treatment (initiated on Day 4) or early antihyperglycemic treatment (initiated on Day 1). Glycemic control targets (7.8-10.0 mmol/L) and insulin therapy follow current clinical guidelines.
The primary outcome is the incidence of poor functional outcome (modified Rankin Scale score ≥ 3) at 90 days. Secondary outcomes include mortality, NIHSS score, GCS score, ICU length of stay, and safety events such as hypoglycemia and infections.
The study aims to provide evidence on the optimal timing of glycemic control in severe stroke patients with stress hyperglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Antihyperglycemic Group | Experimental | Antihyperglycemic treatment is delayed for 72 hours after enrollment. Insulin therapy is initiated on Day 4 targeting blood glucose 7.8-10.0 mmol/L until ICU discharge or Day 14. |
|
| Early Antihyperglycemic Group | Active Comparator | Antihyperglycemic treatment is initiated on Day 1. Insulin therapy targets blood glucose 7.8-10.0 mmol/L until ICU discharge or Day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous insulin | Drug | Insulin administered intravenously to maintain blood glucose between 7.8-10.0 mmol/L. Timing of initiation differs by arm: Day 1 for early group, Day 4 for delayed group. |
| Measure | Description | Time Frame |
|---|---|---|
| Poor Functional Outcome at 90 Days | Proportion of patients with modified Rankin Scale (mRS) score ≥ 3, assessed at 90 days post-randomization. The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death). | from enrollment to day 90 post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality at ICU Discharge or Day 14 | Proportion of patients who die from any cause by ICU discharge or Day 14, whichever occurs first | from admission to ICU discharge within 14 days |
| Neurological Status at ICU Discharge or Day 14 |
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Inclusion Criteria:
1）Severe ischemic stroke: Glasgow Coma Scale (GCS) score ≤ 12 or National Institutes of Health Stroke Scale (NIHSS) score ≥ 15 or CT hypodensity > 1/3 of middle cerebral artery (MCA) territory; 2）Severe intracerebral hemorrhage: Supratentorial hematoma volume ≥ 30 mL (thalamic hemorrhage ≥ 10 mL) or infratentorial hematoma volume ≥ 10 mL (brainstem hemorrhage ≥ 5 mL); 3）Aneurysmal subarachnoid hemorrhage; 3. Blood glucose level > 10 mmol/L at randomization; 4. Signed informed consent.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Neurological function assessed by National Institutes of Health Stroke Scale (NIHSS) score. NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological deficits
| from admission to ICU discharge within 14 days |
| Level of Consciousness at ICU Discharge or Day 14 | Level of consciousness assessed by Glasgow Coma Scale (GCS) score. GCS ranges from 3 to 15, with lower scores indicating impaired consciousness | from admission to ICU discharge within 14 days |
| All-cause Mortality at 90 Days | Proportion of patients who die from any cause within 90 days post-randomization | from admission to discharge at 90 days |
| Length of ICU Stay | Total duration of intensive care unit (ICU) hospitalization, measured in days | From admission to ICU discharge, an average of 11 days |
| Incidence of Adverse Events | Proportion of patients experiencing adverse events during ICU stay, including hypoglycemia (random blood glucose < 3.3 mmol/L), symptomatic hypoglycemia, pulmonary infection, urinary tract infection, and electrolyte disturbances | From randomization to ICU discharge or Day 14, whichever occurs first |
| Incidence of Serious Adverse Events | Proportion of patients experiencing serious adverse events, defined as any event resulting in death, disability, congenital anomaly, or severe hypoglycemia (random blood glucose < 2.22 mmol/L) requiring prolonged hospitalization or re-admission | From randomization to 90 day post-randomization |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |