KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- duration of dependency on intensive care (days in ICU)
研究概览
简要总结
In a previous study, the investigators showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality in adult intensive care patients. Whether this intervention also improves prognosis of pediatric intensive care patients remains unknown. The current prospective, randomized, controlled study will asses the impact of intensive insulin therapy on outcome of patients in a pediatric intensive care unit. On admission patients will be randomly assigned to either strict normalization of blood glucose according age adjusted values or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl to maintain blood glucose levels between 180-200 mg/dl.
详细描述
Study type: Interventional study
Study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children admitted to the pediatric intensive care unit and anticipated to require intensive care for at least 24 hours
排除标准
- •Expected stay < 24 hours
- •Therapy restriction upon admission
- •No informed consent
- •Other study enrollment
研究组 & 干预措施
A
conventional insulin therapy (using Actrapid IV)
干预措施: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia) (Drug)
B
intensive insulin therapy (using actrapid IV)
干预措施: intensive insulin therapy (Actrapid IV to normoglycemia) (Drug)
结局指标
主要结局
duration of dependency on intensive care (days in ICU)
时间窗: time in ICU
Reduction of inflammation
时间窗: during ICU stay to day 5
次要结局
- mortality (safety endpoint)(during time in ICU)
- Duration mechanical ventilation(during time in ICU)
- Organ failure/need for organ support(during time in ICU)
- long-term follow-up study : focus on neurocognitive development (ethical approval granted)(3 years (+/- 6 months) after randomization)
研究者
Greet Van den Berghe
Head of Dept and laboratory of Intensive Care Medicine
KU Leuven