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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Severe Malnutrition

Intervention / Treatment
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* Other: management of severe malnutrition


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Presence of malignancy. Life expectancy of less than 24 hours Presence of advanced Acquired Immunodeficiency Syndrome (AIDS) Aged < 16 years

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| severe malnutrition<br>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. | Other: management of severe malnutrition<br>* multidisciplinary assessment; guideline for the management of severe malnutrition in PUTH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The outcome is the incremental cost of preventing one treatment failure of refeeding syndrome, infection, and all-cause mortality. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe malnutrition, Critically Ill, refeeding syndrome, guideline