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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Peking University Third Hospital

Current Primary Outcome:

  • 28-day change of BMI [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
  • All-cause 28-day mortality [ Time Frame: from admission to 28-day ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The rate of infection in ICU [ Time Frame: from admission to discharge of ICU, an average of length of ICU stay is 28-day ]
  • The rate of refeeding syndrome [ Time Frame: from admission to discharge, an average of length of ICU stay is 28-day ]
  • The rate of complications [ Time Frame: from admission to discharge, an average of length of ICU stay is 28-day ]
  • Length of ICU stay [ Time Frame: from admission to discharge of ICU, an average of length of ICU stay is 28-day ]
  • Cost-effectiveness of treatment [ Time Frame: 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) ]
    The outcome is the incremental cost of preventing one treatment failure of refeeding syndrome, infection, and all-cause mortality.
  • All-cause mortality within six month [ Time Frame: from admission to six month ]
  • Length of hospital stay [ Time Frame: from admission to discharge of hospital, an average of length of hospital stay is three-month ]


Original Secondary Outcome: Same as current

Information By: Peking University Third Hospital

Dates:
Date Received: February 10, 2017
Date Started: October 2016
Date Completion: July 31, 2021
Last Updated: February 13, 2017
Last Verified: February 2017