Nutrition Insights Day Asia
1 other identifier
observational
590
7 countries
89
Brief Summary
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Shorter than P25 for all trials
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Start
First participant enrolled
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2019
CompletedJuly 5, 2019
July 1, 2019
3 months
July 23, 2018
July 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of surgical patients with a caloric / protein deficit receiving EN and/or PN on the day before the NID in selected Asian countries.
Caloric / protein deficit, i.e., difference between energy / protein target per day and actually administered energy/protein
On the day before the Nutrition Insights Day (day -1)
Secondary Outcomes (4)
Absolute and relative caloric and protein balance
On the day before the Nutrition Insights Day (day -1)
Distribution within subcategories of caloric / protein balance
On the day before the Nutrition Insights Day (day -1)
Cumulative (absolute/ relative) caloric and protein balance
On the day before the Nutrition Insights Day (day -1)
Categorical, absolute and relative caloric balance based on standardized target intake (sensitivity analysis)
On the day before the Nutrition Insights Day (day -1)
Study Arms (1)
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
Eligibility Criteria
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
You may qualify if:
- 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
- Hospitalization on SICU or major surgical ward on the NID
- Use of EN (nutritional intake provided via tube feeding) and/or PN for at least one day before the NID
- 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
- Latest surgical intervention ≤ 10 days before NID
You may not qualify if:
- Patients with burn injuries
- Patients requiring postsurgical mechanical ventilation and sedation on the NID
- Patients receiving ON and/or ONS at any quantity on the day before the NID
- Patients requiring emergency procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fresenius Kabilead
- Iqvia Pty Ltdcollaborator
Study Sites (89)
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
Gūrgaon, India
Medanta Medicity Hospital
Gūrgaon, 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
Related Publications (13)
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: 3820522RESULTHigashiguchi 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: 28244696RESULTHo 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: 25175758RESULTJia 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: 26011204RESULTKondrup 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: 12765673RESULTLinthicum 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: 25301845RESULTLiu 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: 27788388RESULTNakahara 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: 28510990RESULTNorman 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: 18061312RESULTSun 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: 26172830RESULTVallejo 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: 28841885RESULTWaitzberg 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: 11448575RESULTZhong 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.
PMID: 26420176RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John F Stover, M.D.
Fresenius Kabi
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2018
First Posted
July 31, 2018
Study Start
March 15, 2019
Primary Completion
June 18, 2019
Study Completion
June 28, 2019
Last Updated
July 5, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share