Clinical trial NCT03055104: Management and Treatment of Patients With Severe Malnutrition in Intensive Care Unit: a Registry
Official title: Management and Treatment of Patients With Severe Malnutrition in Intensive Care Unit: a Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Malnutrition
Keywords: severe malnutrition
Critically Ill
refeeding syndrome
guideline
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with severe malnutrition (BMI \< 13 kg/m2), admitted to PUTH from JAN 2008 are involved in this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 28-day change of BMI
timeFrame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
measure: All-cause 28-day mortality
timeFrame: from admission to 28-day
Secondary outcomes:
measure: The rate of infection in ICU
timeFrame: from admission to discharge of ICU, an average of length of ICU stay is 28-day
measure: The rate of refeeding syndrome
timeFrame: from admission to discharge, an average of length of ICU stay is 28-day
measure: The rate of complications
timeFrame: from admission to discharge, an average of length of ICU stay is 28-day
measure: Length of ICU stay
timeFrame: from admission to discharge of ICU, an average of length of ICU stay is 28-day
measure: Cost-effectiveness of treatment
timeFrame: 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)
measure: All-cause mortality within six month
timeFrame: from admission to six month
measure: Length of hospital stay
timeFrame: from admission to discharge of hospital, an average of length of hospital stay is three-month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Qinggang Ge, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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