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

P

Peking University

Status

Unknown

Conditions

Severe Malnutrition

Treatments

Other: management of severe malnutrition

Study type

Observational

Funder types

Other

Identifiers

NCT03055104
SeNutri-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

severe malnutrition
Description:
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.
Treatment:
Other: management of severe malnutrition

Trial contacts and locations

1

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Central trial contact

Xiaoxiao Li, MSc; Qinggang Ge, M.D.

Data sourced from clinicaltrials.gov

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