Nutrition Insights Day Asia

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606603
• Other study ID #: NScr-002-CNI
• Status: Completed
• Start date: March 15, 2019
• Est. completion date: June 28, 2019

Study information

• Verified date: July 2019
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: June 28, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caloric Deficit
• Malnutrition
• Nutritional Status
• Protein Deficiency

Locations

Country	Name	City	State
India	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	Jaipur
India	Rukmani Birla Hospital, A Unit of CMRI	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	Surat
India	Geetanjali Medical College	Udaipur
India	Christian Medical College & Hospital	Vellore
Indonesia	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
Korea, Republic of	Chungnam National University Hospital	Chungnam
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Sungkunkwan University Samsung Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ulsan University Hospital, Asan Medical Center	Ulsan
Philippines	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 City
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
Taiwan	Changhua Christian Medical Foundation Changhua Christian Hospital	Chang Hua
Taiwan	E-DA Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital- Kaoshiung Branch	Kaohsiung City
Taiwan	Chang Gung Memorial Hospital	Linkou
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
Thailand	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
Vietnam	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	Hu?

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Kabi	IQVIA

Countries where clinical trial is conducted

India,  Indonesia,  Korea, Republic of,  Philippines,  Taiwan,  Thailand,  Vietnam, 

References & 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. — View 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: — View 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: — View 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. — View 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. — View 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 2 — View 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: — View 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 — View Citation

Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. Epub 2007 Dec 3. Review. — View 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):e — View Citation

Vallejo KP, Martínez 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. 201 — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absolute and relative caloric and protein balance	Absolute and relative caloric and protein balance	On the day before the Nutrition Insights Day (day -1)
Secondary	Distribution within subcategories of caloric / protein balance	Distribution within subcategories of caloric / protein balance	On the day before the Nutrition Insights Day (day -1)
Secondary	Cumulative (absolute/ relative) caloric and protein balance	Cumulative (absolute/ relative) caloric and protein balance	On the day before the Nutrition Insights Day (day -1)
Secondary	Categorical, absolute and relative caloric balance based on standardized target intake (sensitivity analysis)	Categorical, absolute and relative caloric balance based on standardized	On the day before the Nutrition Insights Day (day -1)