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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03793244




Registration number
NCT03793244
Ethics application status
Date submitted
23/04/2017
Date registered
4/01/2019
Date last updated
4/01/2019

Titles & IDs
Public title
TARGET-Metabolic Effects
Scientific title
The Augmented Versus Routine Approach to Giving Energy Trial Metabolic Effects Sub-study (TARGET-ME)
Secondary ID [1] 0 0
MC_001 V1 240217
Universal Trial Number (UTN)
Trial acronym
TARGET-ME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Enteral Nutrition 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - TARGET protocol EN 1.5 kcal/mL

Experimental: TARGET protocol EN 1.5 kcal/mL - Enteral (EN) feed 1.5 kcal/mL. Indirect calorimetry and/or VCO2 measurements will be taken periodically while in the TARGET main study

Active Comparator: TARGET protocol EN 1.0 kcal/mL - Enteral feed 1.0 kcal/mL Indirect calorimetry and/or VCO2 measurements will be taken periodically while in the TARGET main study


Treatment: Other: TARGET protocol EN 1.5 kcal/mL
Enteral nutrition
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Calorie difference in kcal
Timepoint [1] 0 0
Up to day 28
Secondary outcome [1] 0 0
Calorie difference in kcal in the whole study cohort
Timepoint [1] 0 0
Up to day 28

Eligibility
Key inclusion criteria
Patients must first meet the inclusion and none of the exclusion criteria for the TARGET main trail (NCT02306746). The following additional criteria applies for this study when indirect calorimetry is being used:

* Within 48 hours of randomisation to TARGET (first measurement only)
* Fi02 < 50% for the past 1 hour
* Positive end expiratory pressure (PEEP) < 12 mmHg for the past 1 hour
* The IC test can be conducted within 48 hours of randomisation to TARGET
* The patient is not considered agitated using the usual site assessment
* There is a clinician available to complete the test
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* There is an air leak in the ventilation circuit (ie bubbling inter-costal catheters, cuff leak at the endotracheal tube
* The patient is receiving renal replacement therapy or extracorporeal membrane oxygenation at the time of measurement
* Has had surgery in the last 6 hours (if enough time within the 48 hour window, consider waiting until this criteria is less than 6 hours)
* If the patient has a traumatic brain injury, for the previous 6 hours, their intracranial pressures have been unstable and in the opinion of the treating intensivist are not controlled
* The treating clinician believes that the IC test will pose risk to the patient

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
ANZIC-RC - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Canberra Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Adelaide Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Auckland City Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Melbourne Health
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The estimation of calorie needs during routine practice in critically ill patients is highly variable and the thermogenic effect of continuous delivery of enteral nutrition (EN) on overall calorie utilisation in critically ill adults is unknown. The TARGET-ME study is a substudy of the TARGET trial (NCT02306746). The TARGET trial provides the perfect opportunity to measure calorie utilisation via indirect calorimetry (IC) and ventilator-derived carbon dioxide production (VCO2) to compare measured calorie utilisation to estimation methods, determine the potential thermic effect of EN solutions with different energy concentrations and investigate any associations with outcome.
Trial website
https://clinicaltrials.gov/study/NCT03793244
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03793244