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)?

Not Applicable

Completed

• Conditions: Clinical Decision Support System
• Interventions: Other: CDSS Canceling

• Registration Number: NCT05670613
• Lead Sponsor: Iaso Maternity Hospital, Athens, Greece

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-12
• Primary Completion: 2022-02-15
• Study Completion: 2022-09-18
• Study First Submitted: 2022-11-17
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-30
• Last Update Submitted: 2022-12-30
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dispense the most effective commercial Solution calculated with the use of the CDSS	CDSS Canceling	Dispensed to patient the most effective commercial solution after the CDSS calculations.
Dispense Ready to Use PN Solutions	CDSS Canceling	Dispensed to patient commercial solution.

Primary Outcome Measures

Name	Time	Method
Estimate of Macro and Micro Nutrient Needs for PN.	0 months - 12 months	Estimation of macro and micro nutrient needs for PN by CDSS: amino acids, carbohydrates, lipid, electrolytes, energy and fluids.
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).	0 months - 12 months	Compare Ready to Use PN solutions with patient's actual nutritional energy needs in order to customize PN for optimum nutrition outcome.
Estimate the difference between actual PN needs and nutrient content of Ready to use Solution for PN available in the market.	0 months - 12 months	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.
Difference of time spent on estimation of PN needs when conducted by hand and CDSS.	0 months - 12 months	Compare time spent for a) calculation of nutritional needs, b) prescription and c) transcription by using CDSS or made by hand.

Trial Locations

Locations (1)

Iaso General Hospital; 🇬🇷 Athens, Greece