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临床试验/NCT05670613
NCT05670613已完成不适用

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?

Iaso Maternity Hospital, Athens, Greece1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2021年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
1
主要终点
Estimate the difference between actual PN needs and nutrient content of Ready to use Solution for PN available in the market.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Dispense Ready to Use PN Solutions

Other

Dispensed to patient commercial solution.

干预措施: CDSS Canceling (Other)

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.

干预措施: CDSS Canceling (Other)

结局指标

主要结局

Estimate the difference between actual PN needs and nutrient content of Ready to use Solution for PN available in the market.

时间窗: 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.

Estimate of Macro and Micro Nutrient Needs for PN.

时间窗: 0 months - 12 months

Estimation of macro and micro nutrient needs for PN by CDSS: amino acids, carbohydrates, lipid, electrolytes, energy and fluids.

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).

时间窗: 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.

Difference of time spent on estimation of PN needs when conducted by hand and CDSS.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Iaso Maternity Hospital, Athens, Greece
申办方类型
Other
责任方
Principal Investigator
主要研究者

Panos Papandreou

Head of Parenteral Nutrition unit, PharmD

Iaso Maternity Hospital, Athens, Greece

研究点 (1)

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