Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
590 participants
OBSERVATIONAL
2019-03-15
2019-06-28
Brief Summary
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This 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.
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Surgical patients
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Hospitalization on SICU or major surgical ward on the NID
3. Use of EN (nutritional intake provided via tube feeding) and/or PN for at least one day before the NID
4. 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
5. Latest surgical intervention ≤ 10 days before NID
Exclusion Criteria
2. Patients requiring postsurgical mechanical ventilation and sedation on the NID
3. Patients receiving ON and/or ONS at any quantity on the day before the NID
4. Patients requiring emergency procedures
18 Years
ALL
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
Fresenius Kabi
INDUSTRY
Responsible Party
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Principal Investigators
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John F Stover, M.D.
Role: STUDY_CHAIR
Fresenius Kabi
Locations
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Manipal Hospital
Bangalore, , India
Bombay Hospital
Bombay, , India
Apollo Hospitals
Chennai, , India
SIMS (SRM Institutes for Medical Science)
Chennai, , India
G. Kuppuswamy Naidu Memorial Hospital
Coimbatore, , India
Max Super Speciality Hospital
Dehli, , India
Sir Ganga Ram Hospital
Dehli, , India
AMRI Hospital
Dhakuria, , India
Fortis Memorial Research Institute
Gurgaon, , India
Medanta Medicity Hospital
Gurgaon, , India
Care Hospital
Hyderabad, , India
Rukmani Birla Hospital, A Unit of CMRI
Jaipur, , India
Rukmani Birla Hospital
Jaipur, , India
Apollo Gleneagles Hospitals Ltd.
Kolkata, , India
Dayanand Medical College and Hospital
Ludhiana, , India
Fortis Hospital
Mohali, , India
Max Superspecialty Hospital
Mohali, , India
B. Y. L. Nair Charitable Hospital & Topiwala National Medical College
Mumbai, , India
S.L Raheja - A Fortis Associate Hospital
Mumbai, , India
BLK Super Specialty Hospital
New Delhi, , India
Jawaharlal Institute Of Post Graduate Medical Education Medical Education and Research (JIPMER)
Puducherry, , India
Deenanath Mangeshkar Hospital
Pune, , India
Ruby Hall Clinic
Pune, , India
Krishna Institute of Medical Sciences
Secunderabad, , India
Surat Institute of Digestive Sciences
Sūrat, , India
Geetanjali Medical College
Udaipur, , India
Christian Medical College & Hospital
Vellore, , India
Cipto Mangunkusumo Hospital
Jakarta, , Indonesia
Dharmais Cancer Center
Jakarta, , Indonesia
Rumah Sakit Persahabatan
Jakarta, , Indonesia
Siloam Hospitals Kebon Jeruk
Jeruk, , Indonesia
Kariadi Hospital
Semarang, , Indonesia
Telogorejo Hospital
Semarang, , Indonesia
Mitra Keluarga Waru Hospital
Waru, , Indonesia
Bethesda Hospital
Yogyakarta, , Indonesia
Sardjito Hospital
Yogyakarta, , Indonesia
Capitol University Medical Center
Cagayan de Oro, , Philippines
Cebu Doctors University Hospital
Cebu City, , Philippines
Perpetual Succour Hospital
Cebu City, , Philippines
De La Salle University Medical Center
Dasmariñas, , Philippines
Southern Philippines Medical Center
Davao City, , Philippines
Makati Medical Center
Makati City, , Philippines
Asian Hospital and Medical Center
Manila, , Philippines
Dr. Jose R.Reyes Memorial Medical Center
Manila, , Philippines
Manila Doctors Hospital
Manila, , Philippines
Philippine General Hospital
Manila, , Philippines
St. Luke's Medical Center Global City
Manila, , Philippines
University of Santo Tomas
Manila, , Philippines
The Medical City
Pasig, , Philippines
East Avenue Medical Center
Quezon City, , Philippines
National Kidney and Transplant Institute
Quezon City, , Philippines
Quirino Memorial Medical Center
Quezon City, , Philippines
St. Luke's Medical Center
Quezon City, , Philippines
Jose B.Lingad Memorial Regional Memorial Hspl
San Fernando City, , Philippines
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Chungnam National University Hospital
Jungnam, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Sungkunkwan University Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Ulsan University Hospital, Asan Medical Center
Ulsan, , South Korea
Changhua Christian Medical Foundation Changhua Christian Hospital
Chang-hua, , Taiwan
Chang Gung Memorial Hospital- Kaoshiung Branch
Kaohsiung City, , Taiwan
E-DA Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital
Linkou District, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Bhumibol Adulyadej Hospital
Bangkok, , Thailand
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Srinakarin Hospital
Bangkok, , Thailand
Thammasat University Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Songkla Nakarin Hospital
Hat Yai, , Thailand
Siriraj Hospital
Phuket, , Thailand
Surin Hospital
Surin, , Thailand
108 Military Central Hospital
Hanoi, , Vietnam
Bach Mai Hospital
Hanoi, , Vietnam
Cho Ray Hospital
Ho Chi Minh City, , Vietnam
HCM city University Medical Center
Ho Chi Minh City, , Vietnam
People's Hospital 115
Ho Chi Minh City, , Vietnam
Thong Nhat Hospital
Ho Chi Minh City, , Vietnam
Hue Central Hospital
Huế, , Vietnam
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NScr-002-CNI
Identifier Type: -
Identifier Source: org_study_id
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