Enteral Nutrition and Glycemic Variability NICU Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Glycemic Variability
研究概览
简要总结
Primary Objective:
To determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose and glycemic variability in a homogenous group of critically ill patients in a neurological ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor. The primary end points will be the difference between the mean blood glucose levels and the glucose variability between the control and intervention groups for the time period that the patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.
Secondary Objectives:
To determine the effects of the diabetes specific versus standard tube feeds on the change in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients ICU stay.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 89 years old
- •Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage
- •Patients who are expected to stay in the ICU for at least 5 days
- •Hyperglycemia is not an inclusion criteria
排除标准
- •Patients who have received or will be treated with systemic corticosteroids.
- •Patients who will be receiving high doses of propofol (>40 cc/hr)
- •Patients with type 1 Diabetes
- •Patients with sepsis or acute trauma
- •Patients with an expected stay in the ICU of less than 4 days
- •Patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components
- •Pregnant and lactating patients
- •Patients with prior history of gastroparesis
- •Patients with acute kidney failure (creatinine > 2.5mg/dl)
- •Patients with acute liver failure (bilirubin > 2.0 mg/dl)
结局指标
主要结局
Glycemic Variability
时间窗: Entire ICU stay. Up to 14 days in the ICU (average about 7 days)
The patients blood glucose levels will be monitored with a continuous blood glucose monitor which records the calibrated blood glucose level every minute. The mean blood glucose over the patients entire ICU stay (up to 14 days) as well as the mathematical variation (fluctuation) in blood glucose levels will be calculated. The degree of glycemic variation will be assessed by a number of mathematical formula, including mean amplitude of glycemic excursions (MAGE). These parameters will be compared between the control and intervention groups.
次要结局
- Quadriceps Muscle Volume(First versus last measurment in ICU. Up to 14 days (average 7 days))
研究者
Paul Marik
Chief of Pulmnary and Critical Care Medicine
Eastern Virginia Medical School