Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D011488', 'term': 'Protein Deficiency'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 590}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2018-07-23', 'studyFirstSubmitQcDate': '2018-07-23', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of surgical patients with a caloric / protein deficit receiving EN and/or PN on the day before the NID in selected Asian countries.', 'timeFrame': 'On the day before the Nutrition Insights Day (day -1)', 'description': 'Caloric / protein deficit, i.e., difference between energy / protein target per day and actually administered energy/protein'}], 'secondaryOutcomes': [{'measure': 'Absolute and relative caloric and protein balance', 'timeFrame': 'On the day before the Nutrition Insights Day (day -1)', 'description': 'Absolute and relative caloric and protein balance'}, {'measure': 'Distribution within subcategories of caloric / protein balance', 'timeFrame': 'On the day before the Nutrition Insights Day (day -1)', 'description': 'Distribution within subcategories of caloric / protein balance'}, {'measure': 'Cumulative (absolute/ relative) caloric and protein balance', 'timeFrame': 'On the day before the Nutrition Insights Day (day -1)', 'description': 'Cumulative (absolute/ relative) caloric and protein balance'}, {'measure': 'Categorical, absolute and relative caloric balance based on standardized target intake (sensitivity analysis)', 'timeFrame': 'On the day before the Nutrition Insights Day (day -1)', 'description': 'Categorical, absolute and relative caloric balance based on standardized'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutritional status', 'malnutrition', 'energy intake', 'protein intake', 'ICU', 'surgical ward', 'hospital', 'enteral nutrition', 'parenteral nutrition', 'nutrition'], 'conditions': ['Nutritional Status', 'Malnutrition', 'Caloric Deficit', 'Protein Deficiency']}, 'referencesModule': {'references': [{'pmid': '3820522', 'type': 'RESULT', 'citation': 'Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.'}, {'pmid': '28244696', 'type': 'RESULT', 'citation': 'Higashiguchi T, Arai H, Claytor LH, Kuzuya M, Kotani J, Lee SD, Michel JP, Nogami T, Peng N. Taking action against malnutrition in Asian healthcare settings: an initiative of a Northeast Asia Study Group. Asia Pac J Clin Nutr. 2017 Mar;26(2):202-211. doi: 10.6133/apjcn.022016.04.'}, {'pmid': '25175758', 'type': 'RESULT', 'citation': 'Ho JW, Wu AH, Lee MW, Lau SY, Lam PS, Lau WS, Kwok SS, Kwan RY, Lam CF, Tam CK, Lee SO. Malnutrition risk predicts surgical outcomes in patients undergoing gastrointestinal operations: Results of a prospective study. Clin Nutr. 2015 Aug;34(4):679-84. doi: 10.1016/j.clnu.2014.07.012. Epub 2014 Aug 1.'}, {'pmid': '26011204', 'type': 'RESULT', 'citation': 'Jia ZY, Yang J, Tong DN, Peng JY, Zhang ZW, Liu WJ, Xia Y, Qin HL. Screening of nutritional risk and nutritional support in general surgery patients: a survey from Shanghai, China. Int Surg. 2015 May;100(5):841-8. doi: 10.9738/INTSURG-D-14-00245.1.'}, {'pmid': '12765673', 'type': 'RESULT', 'citation': 'Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.'}, {'pmid': '25301845', 'type': 'RESULT', 'citation': 'Linthicum MT, Thornton Snider J, Vaithianathan R, Wu Y, LaVallee C, Lakdawalla DN, Benner JE, Philipson TJ. Economic burden of disease-associated malnutrition in China. Asia Pac J Public Health. 2015 May;27(4):407-17. doi: 10.1177/1010539514552702. Epub 2014 Oct 8.'}, {'pmid': '27788388', 'type': 'RESULT', 'citation': 'Liu X, Xu P, Qiu H, Xu D, Li W, Zhan Y, Li Y, Chen Y, Zhou Z, Sun X. Preoperative Nutritional Deficiency Is a Useful Predictor of Postoperative Outcome in Patients Undergoing Curative Resection for Gastric Cancer. Transl Oncol. 2016 Dec;9(6):482-488. doi: 10.1016/j.tranon.2016.09.008. Epub 2016 Oct 24.'}, {'pmid': '28510990', 'type': 'RESULT', 'citation': 'Nakahara S, Nguyen DH, Bui AT, Sugiyama M, Ichikawa M, Sakamoto T, Nakamura T. Perioperative nutrition management as an important component of surgical capacity in low- and middle-income countries. Trop Med Int Health. 2017 Jul;22(7):784-796. doi: 10.1111/tmi.12892. Epub 2017 Jun 13.'}, {'pmid': '18061312', 'type': 'RESULT', 'citation': 'Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. doi: 10.1016/j.clnu.2007.10.007. Epub 2007 Dec 3.'}, {'pmid': '26172830', 'type': 'RESULT', 'citation': 'Sun Z, Kong XJ, Jing X, Deng RJ, Tian ZB. Nutritional Risk Screening 2002 as a Predictor of Postoperative Outcomes in Patients Undergoing Abdominal Surgery: A Systematic Review and Meta-Analysis of Prospective Cohort Studies. PLoS One. 2015 Jul 14;10(7):e0132857. doi: 10.1371/journal.pone.0132857. eCollection 2015.'}, {'pmid': '28841885', 'type': 'RESULT', 'citation': 'Vallejo KP, Martinez CM, Matos Adames AA, Fuchs-Tarlovsky V, Nogales GCC, Paz RER, Perman MI, Correia MITD, Waitzberg DL. Current clinical nutrition practices in critically ill patients in Latin America: a multinational observational study. Crit Care. 2017 Aug 25;21(1):227. doi: 10.1186/s13054-017-1805-z.'}, {'pmid': '11448575', 'type': 'RESULT', 'citation': 'Waitzberg DL, Caiaffa WT, Correia MI. Hospital malnutrition: the Brazilian national survey (IBRANUTRI): a study of 4000 patients. Nutrition. 2001 Jul-Aug;17(7-8):573-80. doi: 10.1016/s0899-9007(01)00573-1.'}, {'pmid': '26420176', 'type': 'RESULT', 'citation': 'Zhong JX, Kang K, Shu XL. Effect of nutritional support on clinical outcomes in perioperative malnourished patients: a meta-analysis. Asia Pac J Clin Nutr. 2015;24(3):367-78. doi: 10.6133/apjcn.2015.24.3.20.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational, cross-sectional study to be conducted on the Nutrition Insights Day (NID), with retrospective review of patient medical charts. No prospective follow-up period is considered.\n\nThis study aims to obtain a contemporary overview of the nutritional status, the use of EN and/or PN and the provision of calories and proteins in patients after major elective gastrointestinal surgery with existing malnutrition or at risk of hospital malnutrition in selected Asian countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients after elective major abdominal gastrointestinal surgery with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications, with indications for nutritional support', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients after elective major abdominal gastrointestinal surgery \\[i.e. elective major GI resections, partial or total, especially for cancer, including: esophagectomy, gastrectomy, enterectomy (small bowel resection), colectomy, hepatectomy, pancreatectomy, resections for gall bladder or bile duct cancer (cholangiocarcinoma)\\] with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications\\*, with indications for nutritional support\n2. Hospitalization on SICU or major surgical ward on the NID\n3. Use of EN (nutritional intake provided via tube feeding) and/or PN for at least one day before the NID\n4. If patient received oral nutrition (ON) or oral nutrition supplements (ONS) during the observational phase from day -5 to day -2, complete and reliable data of daily caloric and protein intake is available\n5. Latest surgical intervention ≤ 10 days before NID\n\nExclusion Criteria:\n\n1. Patients with burn injuries\n2. Patients requiring postsurgical mechanical ventilation and sedation on the NID\n3. Patients receiving ON and/or ONS at any quantity on the day before the NID\n4. Patients requiring emergency procedures'}, 'identificationModule': {'nctId': 'NCT03606603', 'briefTitle': 'Nutrition Insights Day Asia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Nutrition Insights Day Asia to Assess Hospital Malnutrition and the Routine Use of Enteral and Parenteral Nutrition in Patients Following Major Gastrointestinal Surgery', 'orgStudyIdInfo': {'id': 'NScr-002-CNI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical patients', 'description': 'Adult patients after elective major abdominal gastrointestinal surgery with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications, with indications for nutritional support'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangalore', 'country': 'India', 'facility': 'Manipal Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Bombay', 'country': 'India', 'facility': 'Bombay Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Chennai', 'country': 'India', 'facility': 'Apollo Hospitals', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Chennai', 'country': 'India', 'facility': 'SIMS (SRM Institutes for Medical Science)', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Coimbatore', 'country': 'India', 'facility': 'G. Kuppuswamy Naidu Memorial Hospital', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'city': 'Dehli', 'country': 'India', 'facility': 'Max Super Speciality Hospital', 'geoPoint': {'lat': 26.58587, 'lon': 81.22455}}, {'city': 'Dehli', 'country': 'India', 'facility': 'Sir Ganga Ram Hospital', 'geoPoint': {'lat': 26.58587, 'lon': 81.22455}}, {'city': 'Dhakuria', 'country': 'India', 'facility': 'AMRI Hospital', 'geoPoint': {'lat': 27.14965, 'lon': 79.48936}}, {'city': 'Gurgaon', 'country': 'India', 'facility': 'Fortis Memorial Research Institute', 'geoPoint': {'lat': 25.49781, 'lon': 82.15916}}, {'city': 'Gurgaon', 'country': 'India', 'facility': 'Medanta Medicity Hospital', 'geoPoint': {'lat': 25.49781, 'lon': 82.15916}}, {'city': 'Hyderabad', 'country': 'India', 'facility': 'Care Hospital', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Jaipur', 'country': 'India', 'facility': 'Rukmani Birla Hospital, A Unit of CMRI', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Jaipur', 'country': 'India', 'facility': 'Rukmani Birla Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Kolkata', 'country': 'India', 'facility': 'Apollo Gleneagles Hospitals Ltd.', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'city': 'Ludhiana', 'country': 'India', 'facility': 'Dayanand Medical College and Hospital', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}, {'city': 'Mohali', 'country': 'India', 'facility': 'Fortis Hospital', 'geoPoint': {'lat': 30.67995, 'lon': 76.72211}}, {'city': 'Mohali', 'country': 'India', 'facility': 'Max Superspecialty Hospital', 'geoPoint': {'lat': 30.67995, 'lon': 76.72211}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'B. Y. L. 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{'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Linkou District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.07777, 'lon': 121.39348}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Bhumibol Adulyadej Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Rajavithi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Srinakarin Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Thammasat University Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Maharaj Nakorn Chiang Mai Hospital', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Hat Yai', 'country': 'Thailand', 'facility': 'Songkla Nakarin Hospital', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}, {'city': 'Phuket', 'country': 'Thailand', 'facility': 'Siriraj 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{'city': 'Huế', 'country': 'Vietnam', 'facility': 'Hue Central Hospital', 'geoPoint': {'lat': 16.4619, 'lon': 107.59546}}], 'overallOfficials': [{'name': 'John F Stover, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Fresenius Kabi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Iqvia Pty Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}