Nutrition Insights Day Asia

Completed

• Conditions: Malnutrition; Protein Deficiency; Nutritional Status; Caloric Deficit

• Registration Number: NCT03606603
• Lead Sponsor: Fresenius Kabi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-31
• Study Start: 2019-03-15
• Primary Completion: 2019-06-18
• Study Completion: 2019-06-28
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 590

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of surgical patients with a caloric / protein deficit receiving EN and/or PN on the day before the NID in selected Asian countries.	On the day before the Nutrition Insights Day (day -1)	Caloric / protein deficit, i.e., difference between energy / protein target per day and actually administered energy/protein

Secondary Outcome Measures

Name	Time	Method
Absolute and relative caloric and protein balance	On the day before the Nutrition Insights Day (day -1)	Absolute and relative caloric and protein balance
Distribution within subcategories of caloric / protein balance	On the day before the Nutrition Insights Day (day -1)	Distribution within subcategories of caloric / protein balance
Categorical, absolute and relative caloric balance based on standardized target intake (sensitivity analysis)	On the day before the Nutrition Insights Day (day -1)	Categorical, absolute and relative caloric balance based on standardized
Cumulative (absolute/ relative) caloric and protein balance	On the day before the Nutrition Insights Day (day -1)	Cumulative (absolute/ relative) caloric and protein balance

Trial Locations

Locations (89)

Manipal Hospital; 🇮🇳 Bangalore, India

Siloam Hospitals Kebon Jeruk; 🇮🇩 Jeruk, Indonesia

Bombay Hospital; 🇮🇳 Bombay, India

G. Kuppuswamy Naidu Memorial Hospital; 🇮🇳 Coimbatore, India

Max Super Speciality Hospital; 🇮🇳 Dehli, India

Sir Ganga Ram Hospital; 🇮🇳 Dehli, India

AMRI Hospital; 🇮🇳 Dhakuria, India

Care Hospital; 🇮🇳 Hyderabad, India

SIMS (SRM Institutes for Medical Science); 🇮🇳 Chennai, India

Medanta Medicity Hospital; 🇮🇳 Gurgaon, India

Rukmani Birla Hospital; 🇮🇳 Jaipur, India

Kariadi Hospital; 🇮🇩 Semarang, Indonesia

Fortis Memorial Research Institute; 🇮🇳 Gurgaon, India

Dayanand Medical College and Hospital; 🇮🇳 Ludhiana, India

Fortis Hospital; 🇮🇳 Mohali, India

S.L Raheja - A Fortis Associate Hospital; 🇮🇳 Mumbai, India

BLK Super Specialty Hospital; 🇮🇳 New Delhi, India

Deenanath Mangeshkar Hospital; 🇮🇳 Pune, India

Krishna Institute of Medical Sciences; 🇮🇳 Secunderabad, 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

Telogorejo Hospital; 🇮🇩 Semarang, Indonesia

Mitra Keluarga Waru Hospital; 🇮🇩 Waru, Indonesia

Surat Institute of Digestive Sciences; 🇮🇳 Sūrat, India

Bethesda Hospital; 🇮🇩 Yogyakarta, Indonesia

Sardjito Hospital; 🇮🇩 Yogyakarta, Indonesia

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

Ulsan University Hospital, Asan Medical Center; 🇰🇷 Ulsan, Korea, Republic of

Capitol University Medical Center; 🇵🇭 Cagayan De Oro, Philippines

De La Salle University Medical Center; 🇵🇭 Dasmariñas, Philippines

Southern Philippines Medical Center; 🇵🇭 Davao City, Philippines

Sungkunkwan University Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Makati Medical Center; 🇵🇭 Makati City, Philippines

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

St. Luke's Medical Center Global City; 🇵🇭 Manila, Philippines

University of Santo Tomas; 🇵🇭 Manila, Philippines

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Hue Central Hospital; 🇻🇳 Huế, Vietnam

Rukmani Birla Hospital, A Unit of CMRI; 🇮🇳 Jaipur, India

Apollo Hospitals; 🇮🇳 Chennai, India

Jawaharlal Institute Of Post Graduate Medical Education Medical Education and Research (JIPMER); 🇮🇳 Puducherry, India

Apollo Gleneagles Hospitals Ltd.; 🇮🇳 Kolkata, India

B. Y. L. Nair Charitable Hospital & Topiwala National Medical College; 🇮🇳 Mumbai, India

Max Superspecialty Hospital; 🇮🇳 Mohali, India

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Perpetual Succour Hospital; 🇵🇭 Cebu City, Philippines

Asian Hospital and Medical Center; 🇵🇭 Manila, Philippines

Cebu Doctors University Hospital; 🇵🇭 Cebu City, Philippines

Dr. Jose R.Reyes Memorial Medical Center; 🇵🇭 Manila, Philippines

Manila Doctors Hospital; 🇵🇭 Manila, Philippines

Philippine General Hospital; 🇵🇭 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, Philippines

Changhua Christian Medical Foundation Changhua Christian Hospital; 🇨🇳 Chang Hua, Taiwan

E-DA Hospital; 🇨🇳 Kaohsiung, Taiwan

Chang Gung Memorial Hospital- Kaoshiung Branch; 🇨🇳 Kaohsiung City, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Chang Gung Memorial Hospital; 🇨🇳 Linkou, Taiwan

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Bhumibol Adulyadej Hospital; 🇹🇭 Bangkok, Thailand

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand

Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand

Srinakarin Hospital; 🇹🇭 Bangkok, Thailand

Thammasat University Hospital; 🇹🇭 Bangkok, Thailand

Siriraj Hospital; 🇹🇭 Phuket, Thailand

Songkla Nakarin Hospital; 🇹🇭 Hat Yai, Thailand

Maharaj Nakorn Chiang Mai Hospital; 🇹🇭 Chiang Mai, 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

Ruby Hall Clinic; 🇮🇳 Pune, India