Nutrition Insights Day Asia

July 2, 2019 updated by: Fresenius Kabi

Nutrition Insights Day Asia to Assess Hospital Malnutrition and the Routine Use of Enteral and Parenteral Nutrition in Patients Following Major Gastrointestinal Surgery

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

590

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of surgical patients with a caloric / protein deficit receiving EN and/or PN on the day before the NID in selected Asian countries.
Time Frame: 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
On the day before the Nutrition Insights Day (day -1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute and relative caloric and protein balance
Time Frame: On the day before the Nutrition Insights Day (day -1)
Absolute and relative caloric and protein balance
On the day before the Nutrition Insights Day (day -1)
Distribution within subcategories of caloric / protein balance
Time Frame: 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
Time Frame: 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)
Time Frame: On the day before the Nutrition Insights Day (day -1)
Categorical, absolute and relative caloric balance based on standardized
On the day before the Nutrition Insights Day (day -1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi

Collaborators

Iqvia Pty Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2019

Primary Completion (ACTUAL)

June 18, 2019

Study Completion (ACTUAL)

June 28, 2019

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (ACTUAL)

July 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NScr-002-CNI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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