Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Successful weaning from ventilation
研究概览
简要总结
This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study intended to establish 1) the optimal method of determining calorie requirements and 2) the optimal amount of protein supply in chronically ventilated patients.
详细描述
The study will be performed in a chronic ventilation department.
Enrolled patients will be randomly allocated to receive calories as dictated by:
The Harriss-Benedict formula (Group 1) or Indirect Calorimetry (Group 2)
After one week of admission to the hospital department and study enrollment we will review the first results of the study.
After seven days of hospitalization and study enrollment patients who have not been weaned from the ventilator, will be divided into three groups.
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
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronically Mechanical Ventilated Patients (more than 21 days of Mechanical Ventilation) by tracheostomy,
- •Between ages 65-90
排除标准
- •Patient over age 90 and younger the age of 65
- •PH level less than 7.3 due to metabolic causes.
- •A patient with blood albumin level less than 2.2 g / dl
研究组 & 干预措施
Group 1
Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1)
干预措施: Caloric Support (Group 1) (Other)
Group 2
Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2)
干预措施: Caloric Support (Group 2) (Other)
Group 1A
After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups.
Patients in the first(Group 1A)group will receive caloric support calculated by the HARISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight.
干预措施: Protein dose of 1.1 to 1.5 grams per kilogram weight. (Dietary Supplement)
Group 2A
After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups.
Patients in the second group(Group 2A) will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight.
干预措施: Protein at 1.1 grams per kilogram weight. (Dietary Supplement)
Group 3A
After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups.
Patients in the third group will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight.
干预措施: protein at a dose of 1.5 grams per kilogram weight. (Dietary Supplement)
结局指标
主要结局
Successful weaning from ventilation
时间窗: At one, four and eight weeks
Spontaneous breathing
Length of hospital stay
时间窗: At 8 weeks
Length of hospitalization, in days
Readmission to Intensive Care Unit
时间窗: At four and eight weeks.
Readmission to Intensive Care Unit Mortality
时间窗: At eight weeks
Length of mechanical ventilation
时间窗: At one, four and eight weeks
Length of mechanical ventilation in days/hours
次要结局
- Infectious diseases incidence(At one, four and eight weeks)
- Development and progression of pressure ulcers(At one, four and eight weeks)
- Checked daily insulin intake among different groups of patients(After one, four and eight weeks)