Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke: A Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Poor Functional Outcome at 90 Days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Blood glucose level > 10 mmol/L at randomization;
- •Signed informed consent.
排除标准
- •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.
研究组 & 干预措施
Delayed Antihyperglycemic Group
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.
干预措施: Intravenous insulin (Drug)
Early Antihyperglycemic Group
Antihyperglycemic treatment is initiated on Day 1. Insulin therapy targets blood glucose 7.8-10.0 mmol/L until ICU discharge or Day 14.
干预措施: Intravenous insulin (Drug)
结局指标
主要结局
Poor Functional Outcome at 90 Days
时间窗: 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).
次要结局
- All-cause Mortality at ICU Discharge or Day 14(from admission to ICU discharge within 14 days)
- Neurological Status at ICU Discharge or Day 14(from admission to ICU discharge within 14 days)
- Level of Consciousness at ICU Discharge or Day 14(from admission to ICU discharge within 14 days)
- All-cause Mortality at 90 Days(from admission to discharge at 90 days)
- Length of ICU Stay(From admission to ICU discharge, an average of 11 days)
- Incidence of Adverse Events(From randomization to ICU discharge or Day 14, whichever occurs first)
- Incidence of Serious Adverse Events(From randomization to 90 day post-randomization)
研究者
Jie Xu
professor
First Affiliated Hospital of Wannan Medical College