Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous insulin.
- Who it may be relevant to
- Registry conditions: Severe Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke: A Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Clinical Trial
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Poor Functional Outcome at 90 Days [Time frame: from enrollment to day 90 post-enrollment]
Secondary outcome measures (7)
- All-cause Mortality at ICU Discharge or Day 14 [Time frame: from admission to ICU discharge within 14 days]
- Neurological Status at ICU Discharge or Day 14 [Time frame: from admission to ICU discharge within 14 days]
- Level of Consciousness at ICU Discharge or Day 14 [Time frame: from admission to ICU discharge within 14 days]
- All-cause Mortality at 90 Days [Time frame: from admission to discharge at 90 days]
- Length of ICU Stay [Time frame: From admission to ICU discharge, an average of 11 days]
- Incidence of Adverse Events [Time frame: From randomization to ICU discharge or Day 14, whichever occurs first]
- Incidence of Serious Adverse Events [Time frame: From randomization to 90 day post-randomization]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years;
- 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
- Known history of type 1 diabetes mellitus;
- Known allergy to insulin or diagnosis of insulinoma;
- Pre-stroke modified Rankin Scale (mRS) score > 1;
- Hemodynamic instability refractory to medical treatment (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg);
- Decompensated heart failure (New York Heart Association \[NYHA\] class III or IV);
- Estimated glomerular filtration rate (eGFR) < 30 mL/min;
- Expected survival < 90 days due to malignancy;
- Participation in another drug or device clinical trial within the past 30 days;
- Women of childbearing potential who refuse to use effective contraception despite negative pregnancy test, pregnant women, or breastfeeding women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07501533 · 202603