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)?

Study Overview
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Brief Summary
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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.

Official Title
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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?

Conditions
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Clinical Decision Support System

Intervention / Treatment
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* Other: CDSS Canceling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |