Tight Caloric Balance in ICU Patients: a Multicenter, Prospective, Randomized, Controlled Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- Rate of nosocomial infections
研究概览
简要总结
The aim of this study is to perform a prospective, randomized, controlled blinded study in critically patients to assess the necessity for measuring daily resting energy expenditure as a guide for nutritional support. Our hypothesis is that tight caloric control will reduce the rate of new infections.
Study Design :Multi-center, randomized, single blinded, controlled study. Study Population: newly-admitted, adult mechanically ventilated ICU patients.
详细描述
Study objectives
To evaluate the effect of tight caloric control in critical patients on:
- The rate of acquired nosocomial infections (Ventilated associated pneumonia, Catheter related infections, Urinary tract infections)
- Mortality rates, length of stay in the ICU and in hospital, length of ventilation and incidence of non-infectious complications.
Primary endpoint:
Rate of nosocomial infections (for definitions see appendage 1) acquired after 48 to 72 hours following admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Mechanically-ventilated adults(Male or Female)admitted to general ICU within the first 48 hours of ICU admission.
- •Age ≥ 18 years;no upper age limit.
- •Expected stay in ICU> 3 days: [SAPS II (18) > ICU median or high-level of nursing care implemented or per clinical impression of attending physician]
- •Medical and abdomino/thoracic surgery patients, as well as multiple trauma patients with Glasgow Coma Score ≥ 10.
排除标准
- •Readmission in the ICU during the same hospitalization/transfer from other ICU.
- •Admission for postoperative monitoring.
- •Respiratory instability: SpO2 <90% or need for ventilator adjustments during the preceding hour or hyperventilation (Respiratory rate > 35/min)
- •Bicarbonate infusion, loss of bicarbonate (diarrhea, ureterosogmoidostomy or use of acetazoloamide, ultrafiltration).
- •Aerosolization with nitric oxide or heliox, tracheal insufflations or visible leaks in chest drainage system.
- •FiO2 80% or patients requiring prone position
- •Chronic/acute liver failure:Child-Pugh class C
- •Brain injury for various reasons with Glasgow Coma Scale below
- •Cardiac surgery patients.
- •Patients in the hospital for more than 7 days.
- •Contra indication to use enteral nutrition.
- •Participation in a clinical study with an investigational drug within one month prior to the start of this clinical trial.
- •Ethical issues that will influence subject eligibility.
研究组 & 干预措施
Control group
Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the "liberal " regimen, i.e. according to local practice.
Indirect Calorimetry
Study group: Indirect Calorimetry (IC) Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry measurement of Resting Energy Expenditure (REE).
干预措施: Indirect Calorimetry measurement of Resting Energy Expenditure . (Dietary Supplement)
结局指标
主要结局
Rate of nosocomial infections
时间窗: After 48 to 72 hours /daily assessment: within 28 day
Rate of nosocomial infections acquired after 48 to 72 hours following admission up to day 28/or discharge will be evaluated
次要结局
- Caloric control(Day 1 up to day 28/or discharge)
- Metabolic control(Day 1 up to day 28/or discharge)
研究者
Pierre singer
Professor Pierre Singer, MD
Rabin Medical Center