utrition Insights Day Asia to assess hospital malnutrition and the routine use of enteral (passing through intestine) and parenteral (administered in a manner other than through the digestive canal) nutrition in patients following major gastrointestinal surgery

Not Applicable

• Registration Number: CTRI/2019/02/017630
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

During the NID, patient inclusion and data collection will follow the sequence below:

Investigators will identify all potentially eligible patients on the NID by checking if the documentation criteria apply. Only data of patients who are hospitalized on the NID in the SICU or in the major surgical ward will be documented.

For eligible patients, the investigator will start reviewing the patient medical chart to extract all relevant data, including demographic data, nutritional status reflected by the SGA and/or the NRS 2002 (per local routine). Alternative screening tools with confirmed equivalence to either SGA or NRS 2002 might be used; in case multiple screening tools are used, SGA will be the preferred tool for data collection. Additional clinical nutrition-related data corresponding to the previous 1-5 days before the NID will be collected retrospectively. Nutritional data corresponding to the 24 hours before the NID (day -1) will be mandatorily collected. Collection of nutritional data corresponding to day -5 to day -2 before the NID will only be performed if data are available, by medical chart review.

All data collected will be registered in an electronic Case Report Form (eCRF) by the site staff. Patients will provide informed consent before any data is collected, if required by local authorities and regulations.

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 oneday 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 less than or equal 10 days before NID

The determination of pre-existing malnutrition or of a significant risk for malnutrition will be defined by either of the following criteria:

Weight loss greater than 10-15% within the 6 months before the NID

BMI less than 18.5 kg/m2 determined at hospital admission

SGA Grade B and C or NRS 2002 greater than or equal 3 at admission or on the NID (assessed per local routine)

Preoperative serum albumin less than 30 g/l (with no evidence of hepatic or renal

dysfunction), collected per local routine

Patients who are in a well-nourished status at the time of hospital admission, specified as SGA Grade A, NRS 2002 less than 3 or diagnosed as such by equivalent nutrition screening tools, can be included in the observational study if estimated to be at significant risk for post-surgical malnutrition or nutrition-related complications, such as in patients undergoing major GI resections for cancer, or in elderly patients, or inpatient with significant comorbidities.

The information on caloric (Kcal) and protein (g) intake via ON/ONS must be available on a daily basis for the entire duration of th

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
The main interest of the study is the proportion of patients with a caloric/protein deficit on the day before the NID. <br/ ><br>Timepoint: On the NID for up to 5 days before the NID (day -5 to day -1).

Secondary Outcome Measures

Name	Time	Method
Absolute and relative caloric and protein balance <br/ ><br>â?¢ Distribution within subcategories of caloric / protein balance <br/ ><br>â?¢ Cumulative (absolute/ relative) caloric and protein balance <br/ ><br>â?¢ Categorical, absolute and relative caloric balance based on standardized target intake <br/ ><br>(sensitivity analysis) <br/ ><br>Timepoint: On the NID for up to 5 days before the NID (day -5 to day -1).