Severe MalnutritionNCT03055104
Management and Treatment of Patients With Severe Malnutrition in Intensive Care Unit: a Registry
An observational study of Severe Malnutrition, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Severe Malnutrition
- What is being tested?
- management of severe malnutrition
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to 31 Jul 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: The patients with severe malnutrition (BMI < 13 kg/m2), admitted to PUTH from JAN 2008 are involved in this study.
Who may be able to join
- 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.
Who cannot join
- Presence of malignancy.
- Life expectancy of less than 24 hours
- Presence of advanced Acquired Immunodeficiency Syndrome (AIDS)
- Aged < 16 years
Trial locations and contacts
1 site in 1 country.
Qinggang Ge, M.D. contact
Xiaoxiao Li, MSc contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Qinggang Ge, M.D., qingganggelin@126.com
Xiaoxiao Li
About this study
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.
- Conditions
- Severe Malnutrition
- Being tested
- management of severe malnutrition
- Keywords
- severe malnutrition, Critically Ill, refeeding syndrome, guideline
- Medical subject headings
- Malnutrition, Critical Illness, Refeeding Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of severe malnutritionOther
multidisciplinary assessment; guideline for the management of severe malnutrition in PUTH
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: management of severe malnutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day change of BMI
Measured: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
All-cause 28-day mortality
Measured: from admission to 28-day
Secondary outcomes (7)
The rate of infection in ICU
Measured: from admission to discharge of ICU, an average of length of ICU stay is 28-day
The rate of refeeding syndrome
Measured: from admission to discharge, an average of length of ICU stay is 28-day
The rate of complications
Measured: from admission to discharge, an average of length of ICU stay is 28-day
Length of ICU stay
Measured: from admission to discharge of ICU, an average of length of ICU stay is 28-day
Cost-effectiveness of treatment
The outcome is the incremental cost of preventing one treatment failure of refeeding syndrome, infection, and all-cause mortality.
Measured: 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
Measured: from admission to six month
Length of hospital stay
Measured: from admission to discharge of hospital, an average of length of hospital stay is three-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startOct 2016
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Severe MalnutritionStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinggang GE, Peking University Third Hospital
- Investigators
- Qinggang Ge, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055104
- Sponsor's protocol ID
- SeNutri-01
- Status last verified
- Feb 2017
- First submitted
- 10 Feb 2017
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26138740Wassif 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 21367953Aguera 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 26600309Practice 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 10642782National 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 23346610Hebebrand 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 9090350Vignaud 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 20920160Hofer 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 24698345Saito 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Treatment of Patients With Severe Malnutrition in Intensive Care Unit: a Registry
- ClinicalTrials.gov ID
- NCT03055104
- Acronym / sponsor ID
- SeNutri-01
- Conditions
- Severe Malnutrition
- Keywords
- severe malnutrition, Critically Ill, refeeding syndrome, guideline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe malnutrition | – | Other: management of severe malnutritionPatients 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with severe malnutrition (BMI < 13 kg/m2), admitted to PUTH from JAN 2008 are involved in this study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Presence of malignancy.
- Life expectancy of less than 24 hours
- Presence of advanced Acquired Immunodeficiency Syndrome (AIDS)
- Aged < 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| management of severe malnutritionmultidisciplinary assessment; guideline for the management of severe malnutrition in PUTH | Other | severe malnutrition |
Primary outcome
28-day change of BMI
Time frame: 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
7 secondary outcomes
The rate of infection in ICU
Time frame: 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
The rate of complications
Time frame: 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
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)
All-cause mortality within six month
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Results publication: PubMed 26138740Brown 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.
- Results publication: PubMed 21367953Wassif 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.
- Results publication: PubMed 26600309Aguera 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.
- Results publication: PubMed 10642782Practice 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.
- Results publication: PubMed 23346610National 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/
- Results publication: PubMed 9090350Hebebrand 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.
- Results publication: PubMed 20920160Vignaud 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.
- Results publication: PubMed 24698345Hofer 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.
- Results publication: PubMed 24630897Saito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qinggang Ge, M.D. contact
Xiaoxiao Li, MSc contact
Qinggang Ge, M.D. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Malnutrition, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinggang Ge, M.D. (qingganggelin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day change of BMI (time frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055104, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.