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Status unknownNCT03055104Updated Feb 16, 2017

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

An observational study in Severe Malnutrition, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-02-16.

Sponsored by Peking University Third Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
80
Ages
16 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Severe Malnutrition

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Keywords

  • severe malnutrition
  • Critically Ill
  • refeeding syndrome
  • guideline
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In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's planned enrollment of 80 is below the median of 203 across 388 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Presence of malignancy.
  • Life expectancy of less than 24 hours
  • Presence of advanced Acquired Immunodeficiency Syndrome (AIDS)
  • Aged \< 16 years
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
80 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • Othermanagement of severe malnutrition

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

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What researchers measure

Primary outcomes

  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 outcomes

  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

    The outcome is the incremental cost of preventing one treatment failure of refeeding syndrome, infection, and all-cause mortality.

    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)

  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

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Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
    Recruiting
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References and documents

Publications

  • Brown C, Mehler PS. Medical complications of anorexia nervosa and their treatments: an update on some critical aspects. Eat Weight Disord. 2015 Dec;20(4):419-25. doi: 10.1007/s40519-015-0202-3. Epub 2015 Jul 3. PubMed 26138740 ↗
  • Wassif WS, McLoughlin DM, Vincent RP, Conroy S, Russell GF, Taylor NF. Steroid metabolism and excretion in severe anorexia nervosa: effects of refeeding. Am J Clin Nutr. 2011 May;93(5):911-7. doi: 10.3945/ajcn.111.012666. Epub 2011 Mar 2. PubMed 21367953 ↗
  • Aguera Z, Romero X, Arcelus J, Sanchez I, Riesco N, Jimenez-Murcia S, Gonzalez-Gomez J, Granero R, Custal N, Montserrat-Gil de Bernabe M, Tarrega S, Banos RM, Botella C, de la Torre R, Fernandez-Garcia JC, Fernandez-Real JM, Fruhbeck G, Gomez-Ambrosi J, Tinahones FJ, Crujeiras AB, Casanueva FF, Menchon JM, Fernandez-Aranda F. Changes in Body Composition in Anorexia Nervosa: Predictors of Recovery and Treatment Outcome. PLoS One. 2015 Nov 23;10(11):e0143012. doi: 10.1371/journal.pone.0143012. eCollection 2015. PubMed 26600309 ↗
  • Practice guideline for the treatment of patients with eating disorders (revision). American Psychiatric Association Work Group on Eating Disorders. Am J Psychiatry. 2000 Jan;157(1 Suppl):1-39. No abstract available. PubMed 10642782 ↗
  • National Collaborating Centre for Mental Health (UK). Eating Disorders: Core Interventions in the Treatment and Management of Anorexia Nervosa, Bulimia Nervosa and Related Eating Disorders. Leicester (UK): British Psychological Society (UK); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK49304/ PubMed 23346610 ↗
  • Hebebrand J, Himmelmann GW, Herzog W, Herpertz-Dahlmann BM, Steinhausen HC, Amstein M, Seidel R, Deter HC, Remschmidt H, Schafer H. Prediction of low body weight at long-term follow-up in acute anorexia nervosa by low body weight at referral. Am J Psychiatry. 1997 Apr;154(4):566-9. doi: 10.1176/ajp.154.4.566. PubMed 9090350 ↗
  • Vignaud M, Constantin JM, Ruivard M, Villemeyre-Plane M, Futier E, Bazin JE, Annane D; AZUREA group (AnorexieRea Study Group). Refeeding syndrome influences outcome of anorexia nervosa patients in intensive care unit: an observational study. Crit Care. 2010;14(5):R172. doi: 10.1186/cc9274. Epub 2010 Sep 28. PubMed 20920160 ↗
  • Hofer M, Pozzi A, Joray M, Ott R, Hahni F, Leuenberger M, von Kanel R, Stanga Z. Safe refeeding management of anorexia nervosa inpatients: an evidence-based protocol. Nutrition. 2014 May;30(5):524-30. doi: 10.1016/j.nut.2013.09.019. Epub 2014 Jan 29. PubMed 24698345 ↗
  • Saito S, Kobayashi T, Kato S. Management and treatment of eating disorders with severe medical complications on a psychiatric ward: a study of 9 inpatients in Japan. Gen Hosp Psychiatry. 2014 May-Jun;36(3):291-5. doi: 10.1016/j.genhosppsych.2014.02.001. Epub 2014 Feb 10. PubMed 24630897 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03055104
Lead sponsor
Peking University Third Hospital
Responsible party
Qinggang GE (M.D. Chief physician, Peking University Third Hospital) — Principal investigator
First posted
Feb 16, 2017
Start date
Oct 2016
Primary completion
Jul 31, 2021 (estimated)
Completion
Jul 31, 2021 (estimated)
Last update
Feb 16, 2017

Study contacts

Qinggang Ge, M.D.
Contact
qingganggelin@126.com
Xiaoxiao Li, MSc
Contact
lxxsunshine@sina.com
Qinggang Ge, M.D.
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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