NCT00096421已完成3 期
Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study
Hospital Pablo Tobón Uribe2 个研究点 分布在 1 个国家目标入组 504 人开始时间: 2003年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 504
- 试验地点
- 2
- 主要终点
- Mortality in the next 28 days
研究概览
简要总结
The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients.
详细描述
Reduction of morbidity-mortality in critical care patients with tight glycemic control had been proven in surgical patients only.
Study Hypothesis: In critical care patients, medical or surgical, a glucose serum level between 80 - 110 mg/dL means a lower mortality than patients with glucose levels of more than 110 mg/dL.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15 years of age or older,
- •Probability of staying in critical care for more than 48 hours,
- •Agreement with the informed consent.
排除标准
- •Pregnancy,
- •Participating in other trials,
- •Diabetic keto-acidosis or diabetic hyperosmolar state,
- •Do-not-resuscitate orders,
- •Reentry to the critical care unit of the same patient.
结局指标
主要结局
Mortality in the next 28 days
次要结局
- Days of ventilatory support
- Acute renal failure requiring dialysis or hemofiltration
- Mortality during intensive care
- Mortality overall in-hospital
- Mortality among patients who remained in the intensive care unit for more than five days
- Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection
- Length of stay in the unit
- The median number of red-cell transfusions
- SOFA score
- Critical-illness polyneuropathy
研究者
研究点 (2)
Loading locations...
相似试验
终止
3 期
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)LymphomaLeukemiaNCT00500240M.D. Anderson Cancer Center52
已完成
1 期
Phase 1 Study of Potential Anti-Inflammatory Effects of Glucose Control During Acute Myocardial Infarction.Acute Myocardial InfarctionNCT00209144Emory University58
进行中（未招募）
3 期
Tight Versus Liberal Blood Glucose Control in Adult Critically Ill PatientsCritical IllnessHyperglycemiaNCT03665207KU Leuven9,230
已完成
4 期
Intraoperative Glucose Control in Liver TransplantLiver TransplantNCT00780026University of Michigan100
终止
4 期
Tight Intra-Operative Glucose Control During Coronary Artery Bypass SurgeryCoronary Artery BypassNCT00394303Rabin Medical Center1,400