Enteral Nutrition in Critically Ill Patients Undergoing Vasoactive Drugs Therapy. The NUTRIVAD Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 23
- 主要终点
- Enteral nutrition-related mesenteric ischemia.
研究概览
简要总结
Enteral nutrition in critically ill patients undergoing vasoactive support due to hemodynamic instability is controversial. Hypothesis: enteral nutrition delivered in such patients can be feasible and safe.
详细描述
Nutrition support in critically ill patients undergoing vasoactive support due to hemodynamic instability is controversial and challenging. However, if it is delivered according to an enteral nutrition protocol and under proper medical supervision, it can be feasible and safe. The present multicenter prospective study was designed to examine the feasibility and safety of enteral nutrition support in such patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Authorization to participate in the study by informed consent.
- •Dependence of vasoactive drugs and/or mechanical circulatory support to at least 48 hours from Intensive Care Unit admission.
- •Invasive mechanical ventilation time of at least 48 hours.
- •Expected survival greater than 72 hours.
- •ICU Stay greater than or equal to 72 hours.
排除标准
- •Refusal to participate in the study.
- •Refractory shock, defined as the progressive elevation of the dose of vasoactive drugs and / or markers of tissue hypoperfusion, or mean arterial pressure ≤ 60 mm Hg despite the therapeutic maneuvers.
- •History of significant abdominal vascular disease (ischemic colitis, chronic mesenteric ischemia, aortic aneurysm abdominal, aortic dissection with involvement of mesenteric vessels, etc).
- •Absolute contraindication for the onset of enteral nutrition (active gastrointestinal hemorrhage, intestinal obstruction, etc.) or patients with a non-functional gastrointestinal tract.
结局指标
主要结局
Enteral nutrition-related mesenteric ischemia.
时间窗: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Main enteral nutrition- safety related variable, suspected by the presence of warning signs (clinical, analytical, radiological), confirmed by laparotomy/laparoscopy, arteriography or angio-CT.
Dose of vasoactive drugs.
时间窗: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Dose of vasoactive drugs (highest daily), in μg/kg/min.
Kilocalories delivered by enteral route and Energy balance (Kilocalories delivered by enteral nutrition - (minus) enteral nutrition target in Kilocalories).
时间窗: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Main Enteral nutrition efficacy-related variables. Enteral nutrition target was 25 Kilocalories/Kg, if body mass index (BMI) was between 20 and 30. Corrections were made if BMI was under 20/ or over 30.
次要结局
- Abdominal distention.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Regurgitation.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Nasogastric tube complications.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Enteral nutrition interruptions.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Nutrition Tolerance.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- High gastric residual volume.(Daily to a maximum of 14 days after Intensive Care Unit Admission)
- Constipation.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Bronchoaspiration.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Blood lactate.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Cardiac index.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Mechanical circulatory support.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Enteral nutrition-related diarrhea.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Time from Intensive Care Unit admission to the start of enteral nutrition.(Up to 120 hours after Intensive Care Unit Admission.)
研究者
Jose Luis Flordelis Lasierra, MD, PhD
Principal Investigator
Hospital Severo Ochoa