Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06053216
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-08-21
Brief Title:
Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity
Sponsor:
Australian and New Zealand Intensive Care Research Centre
Organization:
Australian and New Zealand Intensive Care Research Centre
Study Overview
Official Title:
GuiDIng Energy Provision Using indiREct CalorimeTry a Pilot Feasibility Randomised Controlled Trial in Critically Ill Adults With Obesity
Status:
RECRUITING
Status Verified Date:
2024-04
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:
DIRECT
Brief Summary:
The DIRECT trial is a prospective multi-centre two arm parallel feasibility pilot randomised controlled trial The primary aim is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity
The trial will recruit 60 mechanically ventilated patients from 4-6 ICUs in Australia and New Zealand
The trial will recruit 60 mechanically ventilated patients from 4-6 ICUs in Australia and New Zealand
Detailed Description:
Indirect calorimetry is the current reference standard for measuring energy expenditure during critical illness allowing for personalisation of energy delivery Use of indirect calorimetry may be important in mitigating under- and overfeeding and associated adverse outcomes This may be particularly important in patients with obesity where energy expenditure is difficult to estimate and limited data is available on the optimal nutritional management of this subgroup
Although access to indirect calorimetry is gradually improving it remains an underutilised tool and skills required to complete and interpret measurements are limited which may hinder use and integration into practice There is a resulting knowledge gap on the impact of indirect calorimetry on outcomes in comparison to standard care predictive equations
A definitive and pragmatic trial is needed to assess the impact of guiding energy delivery with indirect calorimetry on patient outcomes Importantly confirming the feasibility of using indirect calorimetry to guide energy delivery is needed to define optimal measurement protocols prior to completion of a larger trial
The primary aim of the DIRECT trial is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity The secondary aim is to inform a larger trial by collecting process nutrition functional clinical and safety outcomes
The investigators will consider the main trial feasible to conduct if 2 of the following 3 feasibility criteria are achieved a recruitment rate is 1 patient per calendar month b between group separation of 20 in energy adequacy during ICU admission is achieved in relation to measured energy expenditure and c the number of indirect calorimetry measurements completedplanned 60 during ICU admission
Although access to indirect calorimetry is gradually improving it remains an underutilised tool and skills required to complete and interpret measurements are limited which may hinder use and integration into practice There is a resulting knowledge gap on the impact of indirect calorimetry on outcomes in comparison to standard care predictive equations
A definitive and pragmatic trial is needed to assess the impact of guiding energy delivery with indirect calorimetry on patient outcomes Importantly confirming the feasibility of using indirect calorimetry to guide energy delivery is needed to define optimal measurement protocols prior to completion of a larger trial
The primary aim of the DIRECT trial is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity The secondary aim is to inform a larger trial by collecting process nutrition functional clinical and safety outcomes
The investigators will consider the main trial feasible to conduct if 2 of the following 3 feasibility criteria are achieved a recruitment rate is 1 patient per calendar month b between group separation of 20 in energy adequacy during ICU admission is achieved in relation to measured energy expenditure and c the number of indirect calorimetry measurements completedplanned 60 during ICU admission
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