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

Severe Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03055104
• Other study ID #: SeNutri-01
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2017
• Last updated: February 13, 2017
• Start date: October 2016
• Est. completion date: July 31, 2021

Study information

• Verified date: February 2017
• Source: Peking University Third Hospital
• Contact: Qinggang Ge, M.D.
• Email: qingganggelin[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Severe Malnutrition

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

Agüera Z, Romero X, Arcelus J, Sánchez I, Riesco N, Jiménez-Murcia S, González-Gómez J, Granero R, Custal N, Montserrat-Gil de Bernabé M, Tárrega S, Baños RM, Botella C, de la Torre R, Fernández-García JC, Fernández-Real JM, Frühbeck G, Gómez-Ambrosi J, T — View Citation

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. Review. — View Citation

Hebebrand J, Himmelmann GW, Herzog W, Herpertz-Dahlmann BM, Steinhausen HC, Amstein M, Seidel R, Deter HC, Remschmidt H, Schäfer H. Prediction of low body weight at long-term follow-up in acute anorexia nervosa by low body weight at referral. Am J Psychia — View Citation

Hofer M, Pozzi A, Joray M, Ott R, Hähni F, Leuenberger M, von Känel 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day change of BMI		from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Primary	All-cause 28-day mortality		from admission to 28-day
Secondary	The rate of infection in ICU		from admission to discharge of ICU, an average of length of ICU stay is 28-day
Secondary	The rate of refeeding syndrome		from admission to discharge, an average of length of ICU stay is 28-day
Secondary	The rate of complications		from admission to discharge, an average of length of ICU stay is 28-day
Secondary	Length of ICU stay		from admission to discharge of ICU, an average of length of ICU stay is 28-day
Secondary	Cost-effectiveness of treatment	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)
Secondary	All-cause mortality within six month		from admission to six month
Secondary	Length of hospital stay		from admission to discharge of hospital, an average of length of hospital stay is three-month