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临床试验/NCT03055104
NCT03055104Unknown不适用

Management and Treatment of Patients With Severe Malnutrition in Intensive Care Unit: a Registry

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
28-day change of BMI

研究概览

简要总结

Severe malnutrition can be seen as a low BMI, great weight loss, and even low levels of micronutrients. Current studies on severe malnutrition are mainly in patient with anorexia nervosa. The refeeding phase of these high-risk patients bears a further threat to health and potentially fatal complications (such as refeeding syndrome, infection and severe arrhythmia). The objective of this study is to investigate complications due to refeeding of patients with severe malnutrition, as well as their mortality rate, establish and modify the guideline for management of severe malnutrition in Peking University Third Hospital.

详细描述

Severe malnutrition can be seen as a low BMI, great weight loss, and even low levels of micronutrients. Current studies on severe malnutrition are mainly in patient with anorexia nervosa. The refeeding phase of these high-risk patients bears a further threat to health and potentially fatal complications (such as refeeding syndrome, infection and severe arrhythmia).

Intensive care unit of Peking University Third Hospital (PUTH) has treated several patients with severe malnutrition successfully since 2008. Most of these patients had a BMI < 10 (kg/m2) at admission. After admission, a multidisciplinary team, consisting of specialists in the field of intensive care, pharmacy, psychology, and physical therapy assessed all patients. Most of the treatment has been regarded successful with a significant BMI gain and little in-hospital mortality. Based on long-term clinical experience, as well as on evidence-based literature, PUTH nutrition group developed a guideline version 1.0 for the treatment of severe malnutrition in August, 2015.

The objective of this study is to investigate complications due to refeeding of patients with severe malnutrition, as well as their mortality rate, establish and modify the guideline for management of severe malnutrition in PUTH.

This is a single-center, ambispective cohort study. Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: reason for admission, relevant medical history, basic demographic characteristics,anthropometric and clinical data, specific nutrition support regimen and outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with severe malnutrition, admitted to PUTH from JAN
  • (Severe malnutrition is defined as a body mass index (ratio of weight in kg divided by height in m2) < 13)
  • Management and treatment are in accordance with guideline version 1.0 for the treatment of severe malnutrition in PUTH.
  • Patients requiring intensive care unit management who developed life-threatening complications (such as severe fluid/electrolyte disorders, severe arrhythmia) or had single-organ/multiorgan dysfunction.

排除标准

  • Presence of malignancy.
  • Life expectancy of less than 24 hours
  • Presence of advanced Acquired Immunodeficiency Syndrome (AIDS)
  • Aged < 16 years

结局指标

主要结局

28-day change of BMI

时间窗: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

All-cause 28-day mortality

时间窗: from admission to 28-day

次要结局

  • The rate of infection in ICU(from admission to discharge of ICU, an average of length of ICU stay is 28-day)
  • The rate of refeeding syndrome(from admission to discharge, an average of length of ICU stay is 28-day)
  • The rate of complications(from admission to discharge, an average of length of ICU stay is 28-day)
  • Length of ICU stay(from admission to discharge of ICU, an average of length of ICU stay is 28-day)
  • Cost-effectiveness of treatment(from admission to discharge of ICU (an average of length of ICU stay is 28-day), from admission to discharge of hospital (an average of length of hospital stay is three-month))
  • All-cause mortality within six month(from admission to six month)
  • Length of hospital stay(from admission to discharge of hospital, an average of length of hospital stay is three-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qinggang GE

M.D. Chief physician

Peking University Third Hospital

研究点 (1)

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