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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03055104
Enrollment
80
Registered
2017-02-16
Start date
2016-10-31
Completion date
2021-07-31
Last updated
2017-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Malnutrition

Keywords

severe malnutrition, Critically Ill, refeeding syndrome, guideline

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.

Interventions

OTHERmanagement of severe malnutrition

multidisciplinary assessment; guideline for the management of severe malnutrition in PUTH

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
28-day change of BMIfrom admission to 28-day/discharge, an average of length of ICU stay is 28-day
All-cause 28-day mortalityfrom admission to 28-day

Secondary

MeasureTime frameDescription
The rate of complicationsfrom admission to discharge, an average of length of ICU stay is 28-day
Length of ICU stayfrom admission to discharge of ICU, an average of length of ICU stay is 28-day
The rate of infection in ICUfrom admission to discharge of ICU, an average of length of ICU stay is 28-day
All-cause mortality within six monthfrom admission to six month
Length of hospital stayfrom admission to discharge of hospital, an average of length of hospital stay is three-month
Cost-effectiveness of treatmentfrom 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.
The rate of refeeding syndromefrom admission to discharge, an average of length of ICU stay is 28-day

Countries

China

Contacts

Primary ContactQinggang Ge, M.D.
qingganggelin@126.com
Backup ContactXiaoxiao Li, MSc
lxxsunshine@sina.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026