Caloric Deficit, Malnutrition, Nutritional Status, Protein Deficiency
Conditions
Keywords
nutritional status, malnutrition, energy intake, protein intake, ICU, surgical ward, hospital, enteral nutrition, parenteral nutrition, nutrition
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.
Interventions
None listed
Sponsors
Iqvia Pty Ltd
Fresenius Kabi
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Cumulative (absolute/ relative) caloric and protein balance | On the day before the Nutrition Insights Day (day -1) | Cumulative (absolute/ relative) caloric and 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 |
Countries
India, Indonesia, Philippines, South Korea, Taiwan, Thailand, Vietnam
Outcome results
None listed