Clinical Decision Support SystemCDSSNCT05670613
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)?
A study testing CDSS Canceling in people with Clinical Decision Support System, run by Iaso Maternity Hospital, Athens, Greece at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Clinical Decision Support System
- What is being tested?
- CDSS Canceling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteGreece
- Study dates
- 12 Feb 2021to 18 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalize Patients unable to be fed via gastrointestinal tract.
- Hemodynamically stable patients.
- PN regimen should remain the same for the first 3 days.
Who cannot join
- Hemodynamically unstable.
- Anticipated need for parenteral nutrition less than 5 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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?
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.
- Conditions
- Clinical Decision Support System
- Being tested
- CDSS Canceling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDSS CancelingOther
The use of Clinical Decision Support System in Parenteral Nutrition
| Study group | Role | What they receive |
|---|---|---|
| Dispense Ready to Use PN Solutions | Other | Dispensed to patient commercial solution. Receives: Other: CDSS Canceling |
| 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. Receives: Other: CDSS Canceling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 months - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start12 Feb 2021
- Primary completion15 Feb 2022
- Study completion18 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Decision Support SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iaso Maternity Hospital, Athens, Greece
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panos Papandreou, Iaso Maternity Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670613
- Sponsor's protocol ID
- 19042020
- Acronym
- CDSS
- Status last verified
- Dec 2022
- First submitted
- 17 Nov 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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?
- ClinicalTrials.gov ID
- NCT05670613
- Acronym / sponsor ID
- CDSS / 19042020
- Conditions
- Clinical Decision Support System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Iaso Maternity Hospital, Athens, GreeceUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 18 Sep 2022 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dispense Ready to Use PN Solutions | Other | Other: CDSS CancelingDispensed to patient commercial solution. |
| Dispense the most effective commercial Solution calculated with the use of the CDSS | Other | Other: CDSS CancelingDispensed to patient the most effective commercial solution after the CDSS calculations. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalize Patients unable to be fed via gastrointestinal tract.
- Hemodynamically stable patients.
- PN regimen should remain the same for the first 3 days.
Key exclusion criteria (2 listed)
- Hemodynamically unstable.
- Anticipated need for parenteral nutrition less than 5 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDSS CancelingThe use of Clinical Decision Support System in Parenteral Nutrition | Other | Dispense Ready to Use PN Solutions, Dispense the most effective commercial Solution calculated with the use of the CDSS |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDSS Canceling in people with Clinical Decision Support System, run by Iaso Maternity Hospital, Athens, Greece at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate of Macro and Micro Nutrient Needs for PN. (time frame: 0 months - 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.