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

February 13, 2017 updated by: Qinggang GE, Peking University Third Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:
          • Xiaoxiao Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
28-day change of BMI
Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
from admission to 28-day/discharge, an average of length of ICU stay is 28-day
All-cause 28-day mortality
Time Frame: from admission to 28-day
from admission to 28-day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of infection in ICU
Time Frame: from admission to discharge of ICU, an average of length of ICU stay is 28-day
from admission to discharge of ICU, an average of length of ICU stay is 28-day
The rate of refeeding syndrome
Time Frame: from admission to discharge, an average of length of ICU stay is 28-day
from admission to discharge, an average of length of ICU stay is 28-day
The rate of complications
Time Frame: from admission to discharge, an average of length of ICU stay is 28-day
from admission to discharge, an average of length of ICU stay is 28-day
Length of ICU stay
Time Frame: from admission to discharge of ICU, an average of length of ICU stay is 28-day
from admission to discharge of ICU, an average of length of ICU stay is 28-day
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.
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
Time Frame: from admission to six month
from admission to six month
Length of hospital stay
Time Frame: from admission to discharge of hospital, an average of length of hospital stay is three-month
from admission to discharge of hospital, an average of length of hospital stay is three-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Qinggang Ge, M.D., Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SeNutri-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Malnutrition

Clinical Trials on management of severe malnutrition

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe