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Completed

NCT Number: NCT05670613

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)?

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.

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Key information

Conditions

Clinical Decision Support System

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iaso General Hospital

Athens, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CDSS Canceling

Other

The use of Clinical Decision Support System in Parenteral Nutrition

Primary outcomes

  1. 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.

  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).

    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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Iaso Maternity Hospital, Athens, Greece

Other

Registry information

Official study 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?

Acronym: CDSS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2023
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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