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)?

NCT05670613 | Completed

• 1 other identifier: 19042020
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Decision Support System

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Dispense Ready to Use PN Solutions

OTHER

Dispensed to patient commercial solution.

Other: CDSS Canceling

Dispense the most effective commercial Solution calculated with the use of the CDSS

OTHER

Dispensed to patient the most effective commercial solution after the CDSS calculations.

Other: CDSS Canceling

Interventions

CDSS Canceling OTHER

The use of Clinical Decision Support System in Parenteral Nutrition

Dispense Ready to Use PN Solutions; Dispense the most effective commercial Solution calculated with the use of the CDSS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Iaso Maternity Hospital, Athens, Greece: lead

Study Sites (1)

Iaso General Hospital

Athens, Greece

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Parenteral Nutrition unit, PharmD

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: January 4, 2023
• Study Start: February 12, 2021
• Primary Completion: February 15, 2022
• Study Completion: September 18, 2022
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

GR (1)