Clinical trial NCT03606603: Nutrition Insights Day Asia
Official title: Nutrition Insights Day Asia to Assess Hospital Malnutrition and the Routine Use of Enteral and Parenteral Nutrition in Patients Following Major Gastrointestinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Status
Malnutrition
Caloric Deficit
Protein Deficiency
Keywords: nutritional status
malnutrition
energy intake
protein intake
ICU
surgical ward
hospital
enteral nutrition
parenteral nutrition
nutrition
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2018-07-31
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: Inclusion Criteria:

1. 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
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:

1. Patients with burn injuries
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

Primary outcomes:
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)
Secondary outcomes:
measure: Absolute and relative caloric and protein balance
timeFrame: On the day before the Nutrition Insights Day (day -1)
measure: Distribution within subcategories of caloric / protein balance
timeFrame: On the day before the Nutrition Insights Day (day -1)
measure: Cumulative (absolute/ relative) caloric and protein balance
timeFrame: On the day before the Nutrition Insights Day (day -1)
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)
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Manipal Hospital
city: Bombay
country: India
facility: Bombay Hospital
city: Chennai
country: India
facility: Apollo Hospitals
city: Chennai
country: India
facility: SIMS (SRM Institutes for Medical Science)
city: Coimbatore
country: India
facility: G. Kuppuswamy Naidu Memorial Hospital
city: Dehli
country: India
facility: Max Super Speciality Hospital
city: Dehli
country: India
facility: Sir Ganga Ram Hospital
city: Dhakuria
country: India
facility: AMRI Hospital
city: Gurgaon
country: India
facility: Fortis Memorial Research Institute
city: Gurgaon
country: India
facility: Medanta Medicity Hospital
city: Hyderabad
country: India
facility: Care Hospital
city: Jaipur
country: India
facility: Rukmani Birla Hospital, A Unit of CMRI
city: Jaipur
country: India
facility: Rukmani Birla Hospital
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals Ltd.
city: Ludhiana
country: India
facility: Dayanand Medical College and Hospital
city: Mohali
country: India
facility: Fortis Hospital
city: Mohali
country: India
facility: Max Superspecialty Hospital
city: Mumbai
country: India
facility: B. Y. L. Nair Charitable Hospital & Topiwala National Medical College
city: Mumbai
country: India
facility: S.L Raheja - A Fortis Associate Hospital
city: New Delhi
country: India
facility: BLK Super Specialty Hospital
city: Puducherry
country: India
facility: Jawaharlal Institute Of Post Graduate Medical Education Medical Education and Research (JIPMER)
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital
city: Pune
country: India
facility: Ruby Hall Clinic
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences
city: Sūrat
country: India
facility: Surat Institute of Digestive Sciences
city: Udaipur
country: India
facility: Geetanjali Medical College
city: Vellore
country: India
facility: Christian Medical College & Hospital
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
city: Jakarta
country: Indonesia
facility: Dharmais Cancer Center
city: Jakarta
country: Indonesia
facility: Rumah Sakit Persahabatan
city: Jeruk
country: Indonesia
facility: Siloam Hospitals Kebon Jeruk
city: Semarang
country: Indonesia
facility: Kariadi Hospital
city: Semarang
country: Indonesia
facility: Telogorejo Hospital
city: Waru
country: Indonesia
facility: Mitra Keluarga Waru Hospital
city: Yogyakarta
country: Indonesia
facility: Bethesda Hospital
city: Yogyakarta
country: Indonesia
facility: Sardjito Hospital
city: Chungnam
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Sungkunkwan University Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital, Asan Medical Center
city: Cagayan De Oro
country: Philippines
facility: Capitol University Medical Center
city: Cebu City
country: Philippines
facility: Cebu Doctors University Hospital
city: Cebu City
country: Philippines
facility: Perpetual Succour Hospital
city: Dasmariñas
country: Philippines
facility: De La Salle University Medical Center
city: Davao City
country: Philippines
facility: Southern Philippines Medical Center
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Manila
country: Philippines
facility: Asian Hospital and Medical Center
city: Manila
country: Philippines
facility: Dr. Jose R.Reyes Memorial Medical Center
city: Manila
country: Philippines
facility: Manila Doctors Hospital
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Manila
country: Philippines
facility: St. Luke's Medical Center Global City
city: Manila
country: Philippines
facility: University of Santo Tomas
city: Pasig City
country: Philippines
facility: The Medical City
city: Quezon City
country: Philippines
facility: East Avenue Medical Center
city: Quezon City
country: Philippines
facility: National Kidney and Transplant Institute
city: Quezon City
country: Philippines
facility: Quirino Memorial Medical Center
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: San Fernando
country: Philippines
facility: Jose B.Lingad Memorial Regional Memorial Hspl
city: Chang Hua
country: Taiwan
facility: Changhua Christian Medical Foundation Changhua Christian Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Memorial Hospital- Kaoshiung Branch
city: Kaohsiung
country: Taiwan
facility: E-DA Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Linkou
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Bhumibol Adulyadej Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Srinakarin Hospital
city: Bangkok
country: Thailand
facility: Thammasat University Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Hat Yai
country: Thailand
facility: Songkla Nakarin Hospital
city: Phuket
country: Thailand
facility: Siriraj Hospital
city: Surin
country: Thailand
facility: Surin Hospital
city: Hanoi
country: Vietnam
facility: 108 Military Central Hospital
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Cho Ray Hospital
city: Ho Chi Minh City
country: Vietnam
facility: HCM city University Medical Center
city: Ho Chi Minh City
country: Vietnam
facility: People's Hospital 115
city: Ho Chi Minh City
country: Vietnam
facility: Thong Nhat Hospital
city: Huế
country: Vietnam
facility: Hue Central Hospital
Study officials:
affiliation: Fresenius Kabi
name: John F Stover, M.D.
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.