CClinicalTrials.gg
CompletedNCT05670613CDSSUpdated Jan 4, 2023

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)?

An interventional study of CDSS Canceling in Clinical Decision Support System, sponsored by Iaso Maternity Hospital, Athens, Greece. Completed at 1 site in Greece. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by Iaso Maternity Hospital, Athens, Greece · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Feb 2021, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Clinical Decision Support System
03

In context

Lead sponsor

Iaso Maternity Hospital, Athens, Greece is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Hemodynamically unstable.
  • Anticipated need for parenteral nutrition less than 5 days.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • Other
    Dispense Ready to Use PN Solutions

    Dispensed to patient commercial solution.

    Other: CDSS Canceling

  • 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

Interventions

  • OtherCDSS Canceling

    The use of Clinical Decision Support System in Parenteral Nutrition

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0 months - 12 months

  2. 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.

    Time frame: 0 months - 12 months

  3. 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.

    Time frame: 0 months - 12 months

  4. 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.

    Time frame: 0 months - 12 months

  5. 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.

    Time frame: 0 months - 12 months

  6. 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.

    Time frame: 0 months - 12 months

07

Study locations

1 site
  • Iaso General Hospital
    Athens, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05670613
Lead sponsor
Iaso Maternity Hospital, Athens, Greece
Responsible party
Panos Papandreou (Head of Parenteral Nutrition unit, PharmD, Iaso Maternity Hospital, Athens, Greece) — Principal investigator
First posted
Jan 4, 2023
Start date
Feb 12, 2021
Primary completion
Feb 15, 2022
Completion
Sep 18, 2022
Last update
Jan 4, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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