NCT03055104

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

4.8 years

First QC Date

February 10, 2017

Last Update Submit

February 13, 2017

Conditions

Severe Malnutrition

Keywords

severe malnutritionCritically Illrefeeding syndromeguideline

Outcome Measures

Primary Outcomes (2)

  • 28-day change of BMI

    from admission to 28-day/discharge, an average of length of ICU stay is 28-day

  • All-cause 28-day mortality

    from admission to 28-day

Secondary Outcomes (7)

  • The rate of infection in ICU

    from admission to discharge of ICU, an average of length of ICU stay is 28-day

  • The rate of refeeding syndrome

    from admission to discharge, an average of length of ICU stay is 28-day

  • The rate of complications

    from admission to discharge, an average of length of ICU stay is 28-day

  • Length of ICU stay

    from admission to discharge of ICU, an average of length of ICU stay is 28-day

  • Cost-effectiveness of treatment

    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)

  • +2 more secondary outcomes

Study Arms (1)

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

management of severe malnutritionOTHER

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

severe malnutrition

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients with severe malnutrition (BMI \< 13 kg/m2), admitted to PUTH from JAN 2008 are involved in this study.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (9)

  • 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.

    PMID: 26138740RESULT

  • 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.

    PMID: 21367953RESULT

  • 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.

    PMID: 26600309RESULT

  • 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.

    PMID: 10642782RESULT

  • 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/

    PMID: 23346610RESULT

  • 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.

    PMID: 9090350RESULT

  • 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.

    PMID: 20920160RESULT

  • 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.

    PMID: 24698345RESULT

  • 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.

    PMID: 24630897RESULT

MeSH Terms

Conditions

MalnutritionCritical IllnessRefeeding Syndrome

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qinggang Ge, M.D.

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinggang Ge, M.D.

CONTACT

qingganggelin@126.com

Xiaoxiao Li, MSc

CONTACT

lxxsunshine@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Chief physician

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 16, 2017

Study Start

October 1, 2016

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

February 16, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)