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)? (CDSS)

December 30, 2022 updated by: Panos Papandreou, Iaso Maternity Hospital, Athens, Greece

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • IASO general hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dispense Ready to Use PN Solutions
Dispensed to patient commercial solution.
Other: CDSS Canceling
The use of Clinical Decision Support System in Parenteral Nutrition
Other: Dispense the most effective commercial Solution calculated with the use of the CDSS
Dispensed to patient the most effective commercial solution after the CDSS calculations.
Other: CDSS Canceling
The use of Clinical Decision Support System in Parenteral Nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate of Macro and Micro Nutrient Needs for PN.
Time Frame: 0 months - 12 months
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).
Time Frame: 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.
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.
Time Frame: 0 months - 12 months
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.
Time Frame: 0 months - 12 months
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.
Time Frame: 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.
0 months - 12 months
Difference of time spent on estimation of PN needs when conducted by hand and CDSS.
Time Frame: 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.
0 months - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iaso Maternity Hospital, Athens, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2021

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

September 18, 2022

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

December 30, 2022

First Posted (Estimate)

January 4, 2023

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 19042020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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