Intravenous insulin: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years;
2. Severe stroke within 24 hours of onset, meeting one of the following 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:
1. Known history of type 1 diabetes mellitus;
2. Known allergy to insulin or diagnosis of insulinoma;
3. Pre-stroke modified Rankin Scale (mRS) score \> 1;
4. Hemodynamic instability refractory to medical treatment (systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg);
5. Decompensated heart failure (New York Heart Association \[NYHA\] class III or IV);
6. Estimated glomerular filtration rate (eGFR) \< 30 mL/min;
7. Expected survival \< 90 days due to malignancy;
8. Participation in another drug or device clinical trial within the past 30 days;
9. Women of childbearing potential who refuse to use effective contraception despite negative pregnancy test, pregnant women, or breastfeeding women.
Primary outcome measure(s)
Poor Functional Outcome at 90 Days — from enrollment to day 90 post-enrollment 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).
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)
Wuhu
Anhui
Recruiting
More First Affiliated Hospital of Wannan Medical College trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.