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

• Conditions: Severe Malnutrition
• Interventions: Other: management of severe malnutrition

• Registration Number: NCT03055104
• Lead Sponsor: Peking University Third Hospital

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 Description

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.

Study Timeline

• Study Start: 2016-10
• Status Verified: 2017-02
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-13
• Last Update Submitted: 2017-02-13
• Study First Posted: 2017-02-16
• Last Update Posted: 2017-02-16
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients with severe malnutrition, admitted to PUTH from JAN 2008. (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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
severe malnutrition	management of severe malnutrition	Patients with severe malnutrition (BMI\<13 kg/m2), admitted to Peking University Third Hospital from JAN 2008 are involved in this study. After admission, a multidisciplinary team, consisting of specialists in the field of intensive care, pharmacy, psychology, and physical therapy assessed all patients. Management and treatment of these patients are in accordance with guideline for the management of severe malnutrition in PUTH.

Primary Outcome Measures

Name	Time	Method
28-day change of BMI	from admission to 28-day/discharge, an average of length of ICU stay is 28-day
All-cause 28-day mortality	from admission to 28-day

Secondary Outcome Measures

Name	Time	Method
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)	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	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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China