Influence Of Nutritional Status Of Patients In The Intensive Care Output On Long Term Fate
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 680
- 试验地点
- 1
- 主要终点
- all-cause mortality
研究概览
简要总结
It is established that the surviving patients after a stay in the ICU are characterized by frequent malnutrition and morbidity and mortality. The main goal of this work is to study the relationship between nutritional statuses during ICU hospitalization, whatever its determinants, and quality of life, morbidity and mortality at one year.
The hypothesis of the study is that the presence of under nutrition is responsible for a 10% increase in crude mortality at one year (which would be respectively 30% for malnourished patients and 20% for non-malnourished patients).
详细描述
This is a multicenter cohort study of a 30-month follow-up on patients after a stay in ICU.
Nutritional parameters and evaluation of the quality of life will be collected during hospitalization and output during a visit to the Clinical Research Associate at 6 months and one year. Survival will be also noted. These parameters will be studied in comparative patients malnourished and non-malnourished.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Patients of both sexes, age greater than or equal to 18 years
- •Hospitalized more than 72 hours in the ICU
- •Requiring at least one support organ failure:
- •Ventilatory support (invasive or noninvasive)
- •Administration of catecholamines
- •Extrarenal purification whatever technique
- •Affiliated to a social security system
- •Having given free, informed written consent
排除标准
- •Patients with end-stage disease or for which a limitation of care was decided
- •Pregnant women
- •Patients with minor or under guardianship
- •Incapacitated adults and psychiatric inpatients
结局指标
主要结局
all-cause mortality
时间窗: at one year
次要结局
- Post-traumatic stress(at inclusion, M6 and M12)
- Orosomucoid(at inclusion, M6 and M12)
- Anxiety and depression(at inclusion, M6 and M12)
- Quality of life(at M6 and M12)
- Degree of activity (Karnofsky questionnaire)(At M6 and M12)
- Weight(at inclusion, M6 and M12)
- Body mass index(at inclusion, M6 and M12)
- Albumin(at inclusion, M6 and M12)
- Transthyretin (prealbumin)(at inclusion, M6 and M12)
- Body composition(at inclusion, M6 and M12)