"Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care Patients for the Reduction of Complications. Randomized Clinical Trial"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Respiratory Complications
研究概览
简要总结
The goal of this clinical trial is to Determine efficacy of intermittent enteral nutrition vs continuous enteral nutrition in adults patients with a nasogastric tube in a intensive care unit.
The main question[s] it aims to answer are:
- Reduction of gastrointestinal and respiratory complications
- Evaluate the achievement of the caloric objective Informed consent will be requested from participants who meet the inclusion criteria.
The participants will be randomized into two groups: control group (continuous enteral nutrition) or experimental group (intermittent enteral nutrition) Researchers will compare intermittent enteral nutrition vs continuous to see if there is a reduction in gastrointestinal and respiratory complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
By the nature of the intervention(intermittent or continuous administration of enteral nutrition) is impossible to mask it to participats, care provider or investigators.
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
- •Patients admitted to ICU of University General Hospital of Albacete
- •Need for enteral nutrition by nasogastric tube in the first 48 hours
- •Signed informed consent
排除标准
- •Insulin dependent diabetic patients
- •Abdominal surgery
- •Dire prognosis
结局指标
主要结局
Respiratory Complications
时间窗: during ICU stay (maximum 15 days)
Respiratory aspiration of gastric content
Gastrointestinal Complications
时间窗: during ICU stay (maximum 15 days)
Digestive intolerance: Diarrhea, vomiting, increased gastric residual volume(GRV)
次要结局
- ICU Stay(From date of randomization until 100 months)
- Achievement of the caloric objective(during ICU stay (up to 15 days))
- Nutritional status: Biochemical values(up to two days after admission to the ICU)
- Nutritional status: MNA(up to two days after admission to the ICU)
- Changes in blood glucose(during ICU stay (maximum 15 days))
- Mortality(until the date of death from any cause until 100 months)
- Change of type of EN administration(during ICU stay (maximum 15 days))
- Nutritional status:Glim Criteria(up to two days after admission to the ICU)
研究者
Maria Dolores Saiz Vinuesa
Principal Investigator
Complejo Hospitalario Universitario de Albacete