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Nutrition Insights Day Asia

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ClinicalTrials.gov Identifier: NCT03606603
Recruitment Status : Not yet recruiting
First Posted : July 31, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
IQVIA
Information provided by (Responsible Party):
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.


Condition or disease
Nutritional Status Malnutrition Caloric Deficit Protein Deficiency

Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Other
Time Perspective: Retrospective
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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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



Primary Outcome Measures :
  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. [ 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606603


Contacts
Contact: John F Stover, M.D. +49-6172-686 ext 4598 john.stover@fresenius-kabi.com
Contact: Steffen Benzing, Ph.D. +49-6172-686 ext 7709 steffen.benzing@fresenius-kabi.com

Sponsors and Collaborators
Fresenius Kabi
IQVIA
Investigators
Study Chair: John F Stover, M.D. Fresenius Kabi

Publications of Results:

Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT03606603     History of Changes
Other Study ID Numbers: NScr-002-CNI
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fresenius Kabi:
nutritional status
malnutrition
energy intake
protein intake
ICU
surgical ward
hospital
enteral nutrition
parenteral nutrition
nutrition

Additional relevant MeSH terms:
Malnutrition
Protein Deficiency
Nutrition Disorders
Deficiency Diseases