Does a Clinical Support System for Parenteral Nutrition (PN) Facilitate the Judgement on Choosing the Most Effective Commercial Solution Per Patient (and Modify it, if Necessary)?

Clinical Decision Support System Clinical Trial

— CDSS  

Official title:

Does a Clinical Support System for Parenteral Nutrition (PN) Facilitate the Judgement on Choosing the Most Effective Commercial Solution Per Patient (and Modify it, if Necessary)? Is This Solution an Appropriate Alternative to Customized PN for Optimum Nutrition Outcome?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05670613
• Other study ID #: 19042020
• Status: Completed
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: September 18, 2022

Study information

• Verified date: December 2022
• Source: Iaso Maternity Hospital, Athens, Greece
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Standard formulas of PN have been developed and provided to patients. Only few randomized controlled studies compared standardized vs individualized PN. Individually tailored PN, only if standard PN solutions do not meet patient's nutritional needs. ASPEN society recommends the use computerized prescribing. Technology has enabled the incorporation of medical guidelines in CDSSs. New approach: Comparison of patient's calculated nutritional needs with commercial available solutions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 18, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Hospitalize Patients unable to be fed via gastrointestinal tract.
• Hemodynamically stable patients.
• PN regimen should remain the same for the first 3 days.

Exclusion Criteria:

• Hemodynamically unstable.
• Anticipated need for parenteral nutrition less than 5 days.

Related Conditions & MeSH terms

• Clinical Decision Support System

Intervention

Other:
• CDSS Canceling
The use of Clinical Decision Support System in Parenteral Nutrition

Locations

Country	Name	City	State
Greece	Iaso General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Iaso Maternity Hospital, Athens, Greece

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate of Macro and Micro Nutrient Needs for PN.	Estimation of macro and micro nutrient needs for PN by CDSS: amino acids, carbohydrates, lipid, electrolytes, energy and fluids.	0 months - 12 months
Primary	Estimate the difference between actual PN energy needs (kcal per day) and energy provided in the PN solutions available in the market (kcal per 100ml).	Compare Ready to Use PN solutions with patient's actual nutritional energy needs in order to customize PN for optimum nutrition outcome.	0 months - 12 months
Primary	Estimate the difference between actual PN needs and nutrient content of Ready to use Solution for PN available in the market.	Compare Ready to Use PN solutions on total grams of amino acids with patient's actual nutritional needs on total grams of amino acids in order to optimize patient's PN for better nutritional outcome.	0 months - 12 months
Primary	Estimate the difference between actual PN needs and nutrient content of Ready to use Solution for PN available in the market.	Compare Ready to Use PN solutions on total grams of fat with patient's actual nutritional needs on total grams of fat in order to optimize patient's PN for better nutritional outcome.	0 months - 12 months
Primary	Estimate the difference between actual PN needs and nutrient content of Ready to use Solution for PN available in the market.	Compare Ready to Use PN solutions on total grams of carbohydrates with patient's actual nutritional needs on total grams of carbohydrates in order to optimize patient's PN for better nutritional outcome.	0 months - 12 months
Primary	Difference of time spent on estimation of PN needs when conducted by hand and CDSS.	Compare time spent for a) calculation of nutritional needs, b) prescription and c) transcription by using CDSS or made by hand.	0 months - 12 months