Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- Cerebro-Vascular accidents
研究概览
简要总结
Hyperglycemia is a common condition among hospitalized patients. The occurrence of severe hyperglycemia is associated with increased morbidity and mortality in several populations. Several trials assessed the benefits of aggressive versus conventional glucose control. These studies evaluated different patient populations, glucose targets and treatment protocols and as a result reported conflicting results. To date there are no clear guidelines regarding to the preferred glucose target range in hospitalized non-critically ill patients. The common practice is to maintain glucose level lower than 180 mg/dl however there are no evidence based regarding to the outcomes of hospitalized patients treated with intensive compared to conventional glycemic control. This prospective randomized controlled study will compare intensive vs. standard glycemic control in hospitalized non-critically ill patients.
Within 24 hours of hospitalization in the internal medical or geriatric departments, patients who are expected to require hospitalization for at least three consecutive days will be randomly assigned into one of the two study groups - intensive with a target blood glucose range of 130 mg per deciliter or less, or conventional glucose control, with a target of 130-180 mg per deciliter. The investigators defined the primary end point as a composite outcome of mortality in 30 days, severe hypoglycemia, severe infections within 30 days, CVA and cardiac ischemic events within 30 days.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years old.
- •History of type 2 diabetes mellitus for at least three months or a blood glucose level of 200 mg per deciliter or higher in two different consecutive measurements.
- •A minimum of three days of hospitalization.
排除标准
- •Diabetic ketoacidosis or hyperosmolar non-ketotic state.
- •Patients expected to require intensive care unit admission or immediate surgical intervention.
- •History of current drug or alcohol abuse.
- •History of current mental illness.
- •Child-bearing potential or a positive urine pregnancy test.
研究组 & 干预措施
Intensive glycemic control
With a target of blood glucose range of 130 mg/dL or less
干预措施: Insulin (Drug)
Conventional glycemic control
With a target of blood glucose range of 130-180 mg/dL
干预措施: Insulin (Drug)
结局指标
主要结局
Cerebro-Vascular accidents
时间窗: 30 days
Composite outcome of: 1. mortality in 30 days
时间窗: 30 days
Severe hypoglycemia
时间窗: 30 days
Severe infections
时间窗: 30 days
Severe infections will be defined as a hospitalization as a result of sepsis, pneumonia or soft tissue infection or other infection requiring intravenous antibiotic therapy that occurred during hospitalization.
Cardiac ischemic events
时间窗: 30 days
次要结局
- Length of hospitalization(90 days)
- Repeat hospitalizations within 90 days(90 days)
- Each component of the primary outcomes(30 days)
- Severe infections within 90 days(90 days)
研究者
Irit Ayalon Dangur, MD
Dr, Internal Medicine Doctor, Principal Investigator
Rabin Medical Center