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

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ClinicalTrials.gov Identifier: NCT03055104
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Qinggang GE, 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.

Condition or disease Intervention/treatment
Severe Malnutrition Other: management of severe malnutrition

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 6 Months
Official Title: Management and Treatment of Patients With Severe Malnutrition in Intensive Care Unit: a Registry
Actual Study Start Date : October 2016
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Group/Cohort Intervention/treatment
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.
Other: management of severe malnutrition
multidisciplinary assessment; guideline for the management of severe malnutrition in PUTH




Primary Outcome Measures :
  1. 28-day change of BMI [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
  2. All-cause 28-day mortality [ Time Frame: from admission to 28-day ]

Secondary Outcome Measures :
  1. The rate of infection in ICU [ Time Frame: from admission to discharge of ICU, an average of length of ICU stay is 28-day ]
  2. The rate of refeeding syndrome [ Time Frame: from admission to discharge, an average of length of ICU stay is 28-day ]
  3. The rate of complications [ Time Frame: from admission to discharge, an average of length of ICU stay is 28-day ]
  4. Length of ICU stay [ Time Frame: from admission to discharge of ICU, an average of length of ICU stay is 28-day ]
  5. Cost-effectiveness of treatment [ Time Frame: 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.

  6. All-cause mortality within six month [ Time Frame: from admission to six month ]
  7. Length of hospital stay [ Time Frame: from admission to discharge of hospital, an average of length of hospital stay is three-month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055104


Contacts
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Contact: Qinggang Ge, M.D. qingganggelin@126.com
Contact: Xiaoxiao Li, MSc lxxsunshine@sina.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Qinggang Ge, M.D.       qingganggelin@126.com   
Contact: Xiaoxiao Li         
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: Qinggang Ge, M.D. Peking University Third Hospital

Additional Information:

Publications of Results:

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Responsible Party: Qinggang GE, M.D. Chief physician, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03055104     History of Changes
Other Study ID Numbers: SeNutri-01
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qinggang GE, Peking University Third Hospital:
severe malnutrition
Critically Ill
refeeding syndrome
guideline

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders