Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Hospital mortality
研究概览
简要总结
To explore whether serial changes of data in body composition of patients with sepsis can help clinician to monitor prognosis.
详细描述
The investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the intervention group will be given to the dietitians for adjusting the diet formula according to the patient's body composition.The patients in control group also will undergo Bio-electrical Impedance Analysis (BIA) assessment, but not disclosed to the dietitian. The diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patient
- •Clinical diagnosis of sepsis
排除标准
- •Expired within 3-days
结局指标
主要结局
Hospital mortality
时间窗: The day discharged from hospital, an average of 5 weeks
Status of survival or mortality at the time discharged from hospital
90-day mortality
时间窗: Day 90 after hospital admission
Status of survival or mortality at Day 90 during hospital stay
7-day mortality
时间窗: Day 7 after hospital admission
Status of survival or mortality at Day 7 during hospital stay
ICU mortality
时间窗: The day discharged from ICU, an average of 2 weeks
Status of survival or mortality at the time discharged from ICU
28-day mortality
时间窗: Day 28 after hospital admission
Status of survival or mortality at Day 28 during hospital stay
次要结局
- Change of white blood cell between day 1 and day 3(Day 1 and Day 3 after ICU admission)
- Change of percentage of body fat between day 1 and day 8(Day 1 and Day 8 after ICU admission)
- Change of protein intake between day 1 and day 3(Day 1 and Day 3 after ICU admission)
- Change of energy intake between day 1 and day 3(Day 1 and Day 3 after ICU admission)
- Change of energy intake between day 1 and day 8(Day 1 and Day 8 after ICU admission)
- Change of total body water between day 1 and day 3(Day 1 and Day 3 after ICU admission)
- Change of pulse pressure between day 1 and day 3(Day 1 and Day 3 after ICU admission)
- Change of pulse pressure between day 3 and day 8(Day 3 and Day 8 after ICU admission)
- Ventilation days(The day weaned off ventilator, an average of 3 weeks)
- Change of protein intake between day 3 and day 8(Day 3 and Day 8 after ICU admission)
- Change of segment/monocyte ratio between day 1 and day 3(Day 1 and Day 3 after ICU admission)
- Change of white blood cell between day 1 and day 8(Day 1 and Day8 after ICU admission)
- Change of pulse pressure between day 1 and day 8(Day 1 and Day 8 after ICU admission)
- Day 1 Sequential Organ Failure Assessment score(Day 1 after ICU admission)
- Day 8 Sequential Organ Failure Assessment score(Day 8 after ICU admission)
- Change of percentage of body fat between day 1 and day 3(Day 1 and Day 3 after ICU admission)
- Change of protein intake between day 1 and day 8(Day 1 and Day 8 after ICU admission)
- Change of white blood cell between day 3 and day 8(Day 3 and Day 8 after ICU admission)
- Change of energy intake between day 3 and day 8(Day 3 and Day 8 after ICU admission)
- Change of soft lean mass between day 1 and day 8(Day 1 and Day 8 after ICU admission)
- Day 3 Sequential Organ Failure Assessment score(Day 3 after ICU admission)
- Change of percentage of body fat between day 3 and day 8(Day 3 and Day 8 after ICU admission)
- Change of segment/monocyte ratio between day 1 and day 8(Day 1 and Day 8 after ICU admission)
- Change of total body water between day 1 and day 8(Day 1 and Day 8 after ICU admission)
- Change of segment/monocyte ratio between day 3 and day 8(Day 3 and Day 8 after ICU admission)
- Change of total body water between day 3 and day 8(Day 3 and Day 8 after ICU admission)
- Change of soft lean mass between day 1 and day 3(Day 1 and Day 3 after ICU admission)
- Change of soft lean mass between day 3 and day 8(Day 3 and Day 8 after ICU admission)
- ICU Days(The day discharged from ICU, an average of 2 weeks)