Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-17 @ 7:12 PM
Study NCT ID:
NCT03055104
Status:
UNKNOWN
Last Update Posted:
2017-02-16
First Post:
2017-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management and Treatment of Patients With Severe Malnutrition in Intensive Care Unit: a Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D055677', 'term': 'Refeeding Syndrome'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2017-02-10', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day change of BMI', 'timeFrame': 'from admission to 28-day/discharge, an average of length of ICU stay is 28-day'}, {'measure': 'All-cause 28-day mortality', 'timeFrame': 'from admission to 28-day'}], 'secondaryOutcomes': [{'measure': 'The rate of infection in ICU', 'timeFrame': 'from admission to discharge of ICU, an average of length of ICU stay is 28-day'}, {'measure': 'The rate of refeeding syndrome', 'timeFrame': 'from admission to discharge, an average of length of ICU stay is 28-day'}, {'measure': 'The rate of complications', 'timeFrame': 'from admission to discharge, an average of length of ICU stay is 28-day'}, {'measure': 'Length of ICU stay', 'timeFrame': 'from admission to discharge of ICU, an average of length of ICU stay is 28-day'}, {'measure': 'Cost-effectiveness of treatment', 'timeFrame': '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)', 'description': 'The outcome is the incremental cost of preventing one treatment failure of refeeding syndrome, infection, and all-cause mortality.'}, {'measure': 'All-cause mortality within six month', 'timeFrame': 'from admission to six month'}, {'measure': 'Length of hospital stay', 'timeFrame': 'from admission to discharge of hospital, an average of length of hospital stay is three-month'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe malnutrition', 'Critically Ill', 'refeeding syndrome', 'guideline'], 'conditions': ['Severe Malnutrition']}, 'referencesModule': {'references': [{'pmid': '26138740', 'type': 'RESULT', '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. Epub 2015 Jul 3.'}, {'pmid': '21367953', 'type': 'RESULT', '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. Epub 2011 Mar 2.'}, {'pmid': '26600309', 'type': 'RESULT', 'citation': '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': '10642782', 'type': 'RESULT', '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. No abstract available.'}, {'pmid': '23346610', 'type': 'RESULT', '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. Available from http://www.ncbi.nlm.nih.gov/books/NBK49304/'}, {'pmid': '9090350', 'type': 'RESULT', 'citation': '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': '20920160', 'type': 'RESULT', '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. 2010;14(5):R172. doi: 10.1186/cc9274. Epub 2010 Sep 28.'}, {'pmid': '24698345', 'type': 'RESULT', 'citation': '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': '24630897', 'type': 'RESULT', '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. Epub 2014 Feb 10.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nIntensive 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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients with severe malnutrition (BMI \\< 13 kg/m2), admitted to PUTH from JAN 2008 are involved in this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Management and treatment are in accordance with guideline version 1.0 for the treatment of severe malnutrition in PUTH.\n* 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.\n\nExclusion Criteria:\n\n* Presence of malignancy.\n* Life expectancy of less than 24 hours\n* Presence of advanced Acquired Immunodeficiency Syndrome (AIDS)\n* Aged \\< 16 years'}, 'identificationModule': {'nctId': 'NCT03055104', 'briefTitle': 'Management and Treatment of Patients With Severe Malnutrition in Intensive Care Unit: a Registry', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Management and Treatment of Patients With Severe Malnutrition in Intensive Care Unit: a Registry', 'orgStudyIdInfo': {'id': 'SeNutri-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'severe malnutrition', 'description': '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.', 'interventionNames': ['Other: management of severe malnutrition']}], 'interventions': [{'name': 'management of severe malnutrition', 'type': 'OTHER', 'description': 'multidisciplinary assessment; guideline for the management of severe malnutrition in PUTH', 'armGroupLabels': ['severe malnutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qinggang Ge, M.D.', 'role': 'CONTACT', 'email': 'qingganggelin@126.com'}, {'name': 'Xiaoxiao Li', 'role': 'CONTACT'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qinggang Ge, M.D.', 'role': 'CONTACT', 'email': 'qingganggelin@126.com'}, {'name': 'Xiaoxiao Li, MSc', 'role': 'CONTACT', 'email': 'lxxsunshine@sina.com'}], 'overallOfficials': [{'name': 'Qinggang Ge, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. Chief physician', 'investigatorFullName': 'Qinggang GE', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}