Glycaemic Alterations in ICU: an Observational, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Change in glycaemic blood levels during ICU stay
研究概览
简要总结
To quantify the local prevalence of diabetes mellitus in critically ill patients. To understand whether a correlation does exist between premorbid glycaemic control and glycaemic status in ICU. A subgroup analysis will be conducted to investigate whether a relationship does exist between Neuron Specific Enolase levels and glycaemic disorders.
详细描述
The aim of this study is to determine the local prevalence of critical illness-associated hyperglycaemia (CIAH) and recognised and unrecognised diabetes, as well as to evaluate how premorbid glycaemia impacts the relationship between three glycaemic domains and mortality.
The investigators will calculate the Time In Range (TIR, 70-180 mg/dl) and evaluate distribution of percentage time in range for non-diabetics and diabetics patients, in order to understand the association between TIR and survival in both groups of patients (patients with diabetes and patients without diabetes).
In view of the potential adverse effects of hyperglycaemia, hypoglycaemia and glycaemic variability on the brain, the investigators will dose Neuron Specific Enolase in critically ill patients.
The aim is to define if a biochemical correlation does exist between critically ill dysglycaemia and NSE plasma concentration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ICU patients
- •expected ICU length of stay > 48 hours
排除标准
- •age <18 years
- •ICU length of stay <48 hours
- •diabetic ketoacidosis
- •hyperosmolar nonketonic hyperglycaemia syndrome
- •pregnancy
- •hypoglycaemic coma
- •acute or acute on chronic liver failure, liver transplantation or end-stage liver disease.
结局指标
主要结局
Change in glycaemic blood levels during ICU stay
时间窗: Glycaemic values expressed as mean glycaemia will be collected at the baseline and every 8 hours for the duration of ICU stay, expected average of 10 days per patient.
次要结局
- Coefficient of variation of blood glucose levels(Time point A:24 hours. Time point B: 48 hours after ICU admission. Time point C: for the duration of ICU stay, an expected average of 10 days per patient.)
- Episodes of hyperglycaemia (number)(For the duration of ICU stay, expected average of 10 days per patient.)
- Days of continuous renal replacement therapy(Participants will be followed for the duration of ICU stay, expected average per patient: 10 days)
- Neuron Specific Enolase (NSE) blood levels and glycaemic disorders(NSE collection: Time point A: ICU admission. Time point NSE: 48-72 hours after ICU admission)
- Days of mechanical ventilation(Participants will be followed for the duration of ICU stay, expected average per patient: 10 days)
- Time in glycaemic Range (TIR)(Time point A:24 hours. Time point B: 48 hours after ICU admission. Time point C: for the duration of ICU stay, an expected average of 10 days per patient.)
- Episodes of hypoglicaemia (number)(For the duration of ICU stay, expected average of 10 days per patient.)
研究者
Francesca Di Muzio
Medical Doctor
Catholic University of the Sacred Heart