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Completed

NCT Number: NCT03606603

Nutrition Insights Day Asia

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.

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Key information

Conditions

Nutritional Status Caloric Deficit Deficiency Diseases Hyperphagia Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Protein Deficiency Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manipal Hospital, Bangalore, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Hospitalization on SICU or major surgical ward on the NID
  • Use of EN (nutritional intake provided via tube feeding) and/or PN for at least one day before the NID
  • 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
  • Latest surgical intervention ≤ 10 days before NID

Exclusion criteria

  • Patients with burn injuries
  • Patients requiring postsurgical mechanical ventilation and sedation on the NID
  • Patients receiving ON and/or ONS at any quantity on the day before the NID
  • Patients requiring emergency procedures

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2018
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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