Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342895
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-03-26
Brief Title:
Interpretation and Optimization of Nutrition in the Intensive Care Units
Sponsor:
Dim3
Organization:
Dim3
Study Overview
Official Title:
Interpretation and Optimization of Nutrition in the Intensive Care Units
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IONIC
Brief Summary:
Despite recommendations inadequate nutritional intake in intensive care unit ICU patients remains frequent and can lead to complications such as infections increased length of stay prolonged weaning from ventilation increased long-term mortality and decreased quality of life after intensive care Studies have shown that patients only receive up to 50-60 of prescribed calories and proteins due to many factors leading to nutritional support interruptions such as ICU procedures physical therapy transport for imaging or invasive procedures outside the ICU and nutrition intolerance
Furthermore this discrepancy between prescribed and delivered nutrition may go largely unnoticed due to issues concerning inadequate manual or automated monitoring of delivered nutrition A joint Call to Action by ASPEN the Academy of Nutrition and Dietetics and the American Society of Health-System Pharmacists stated that parenteral nutrition errors and their contributing factors could be prevented by improving the functionality of in-house Clinical Decision Support Systems and the interfaces between electronic health records EHRs automated preparation devices and pharmacy systems
Nutrow is a software package designed to support nutritional management based on the calculation of recommended calorie and protein requirements real-time calculation and monitoring of calorie and protein prescriptions real-time calculation and monitoring of calories and protein truly delivered to patients and information feedback to prescribers Feedim is a Medical Device Data System MDDS designed by Dim3 which transmits information from enteral feeding pumps to third-party software such as Nutrow
The aim of the study is to assess whether the joint use of Nutrow-Feedim improves the achievement of nutritional objectives in ICU patients prior to oral intake by reducing the discrepancy between prescribed and delivered calories and protein
Furthermore this discrepancy between prescribed and delivered nutrition may go largely unnoticed due to issues concerning inadequate manual or automated monitoring of delivered nutrition A joint Call to Action by ASPEN the Academy of Nutrition and Dietetics and the American Society of Health-System Pharmacists stated that parenteral nutrition errors and their contributing factors could be prevented by improving the functionality of in-house Clinical Decision Support Systems and the interfaces between electronic health records EHRs automated preparation devices and pharmacy systems
Nutrow is a software package designed to support nutritional management based on the calculation of recommended calorie and protein requirements real-time calculation and monitoring of calorie and protein prescriptions real-time calculation and monitoring of calories and protein truly delivered to patients and information feedback to prescribers Feedim is a Medical Device Data System MDDS designed by Dim3 which transmits information from enteral feeding pumps to third-party software such as Nutrow
The aim of the study is to assess whether the joint use of Nutrow-Feedim improves the achievement of nutritional objectives in ICU patients prior to oral intake by reducing the discrepancy between prescribed and delivered calories and protein
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A00103-40 | OTHER | ID-RCB number ANSM | None |