How Well do we Feed the Critically Ill Patients: a Multicentric, Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Calorie and protein balance
研究概览
简要总结
The present prospective observational multicentric study will assess the nutritional status of critically ill patients, cumulative calorie and protein balance and the effect of calorie and protein balance on clinical outcomes.
详细描述
Nutritional therapy is a very important aspect of the management of critically ill patients. These patients need intensive monitoring, various organ supports in the form of vasopressors and inotropes, mechanical ventilation, dialysis, extracorporeal organ supports, infection controls, etc. In this very complex, critical and demanding scenario, nutritional therapy often gets a back seat in the initial period at least till the time patient is stabilised. But this nutritional deprivation has much more deleterious effects in sepsis and systemic inflammatory response syndromes induced catabolic state than that of fasting in healthy persons. Various studies showed that inadequate feeding has been associated with an increased hospital length of stay, incidence of complications, infections, incidence of organ failure, and risk of mortality. A single centre prospective study that analyzed 768 patients reported that 69% were calorie deficient and 90% were protein deficient. They also observed a positive correlation between calorie deficit and infectious complications, length of Intensive Care Unit (ICU) stay and days of mechanical ventilation.
The main factors may hinder enteral feeding and adequate nutrition delivery. That includes delay in the initiation of Enteral Nutrition (EN) and slow infusion rate; low adherence to EN practice guidelines; frequent disruptions to EN due to diagnostic or therapeutic procedures.
In observational studies, patients in the ICU who were fed early through the enteral route have had a better outcome than those who were not. Similarly, overfeeding has also been associated with various complications, including hyperglycemia, hypertriglyceridemia, hepatic steatosis, azotemia, hypercapnia, and an increased rate of mortality among patients.
Therefore, optimum nutrition is vital to a patient's survival. The present prospective observational multicentric study will assess the nutritional status of critically ill patients, cumulative calorie and protein balance and the effect of calorie and protein balance on clinical outcome
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •All adult patients who receive either enteral or parenteral nutrition will be included in the study.
排除标准
- •Age less than 18 years old
- •Pregnant women
- •Patient is expected to die within 48 hours of ICU admission.
结局指标
主要结局
Calorie and protein balance
时间窗: From day of randomization till 7 days, or the patient is discharged from ICU, or death of the patient, whichever is earlier.
Cumulative calorie and protein balance.
次要结局
- Length of ICU stay(From the day of randomization till the patient is shifted out of ICU, or death of the patient, or 28 days of ICU admission, whichever is earlier.)
- Mortality(From the day of randomisation to 28 days of ICU admission.)
- Days of Mechanical Ventilation(From day of randomization till the patient is removed from mechanical ventilation, or 28 days of ICU admission, or death of the patient, whichever is earlier)
- Time to initiation of enteral or parenteral nutrition(From the day of randomisation till 28 days of ICU admission, or death of the patient, whichever is earlier)
研究者
Prashant Nasa
HOD, Critical Care Medicine
NMC Specialty Hospital