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

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

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