Critical IllnessTARGET-MENCT03793244
TARGET-Metabolic Effects
An observational study of Critical Illness and Enteral Nutrition, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Enteral Nutrition
- What is being tested?
- TARGET protocol EN 1.5 kcal/mL
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2017to 1 Aug 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients who are mechanically ventilated
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Augmented Versus Routine Approach to Giving Energy Trial Metabolic Effects Sub-study (TARGET-ME)
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.
- Conditions
- Critical Illness, Enteral Nutrition
- Being tested
- TARGET protocol EN 1.5 kcal/mL
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARGET protocol EN 1.5 kcal/mLDietary supplement
Enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: TARGET protocol EN 1.5 kcal/mL | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calorie difference in kcal
Difference in mean calorie delivery and mean measured calorie utilisation over the study period (expressed as a percentage of measured requirements received) in each study group
Measured: Up to day 28
Secondary outcomes (1)
Calorie difference in kcal in the whole study cohort
Calorie difference in kcal between mean calorie delivery and mean measured calorie utilisation over the study period (expressed as a percentage of measured requirements received) in the whole study cohort
Measured: Up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Jul 2017
- Primary completion10 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- The Canberra Hospital, Royal Adelaide Hospital, Auckland City Hospital, Melbourne Health
- Responsible party
- Principal investigator, anzicrc, Australian and New Zealand Intensive Care Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793244
- Sponsor's protocol ID
- MC_001 V1 240217
- Acronym
- TARGET-ME
- Status last verified
- Jan 2019
- First submitted
- 23 Apr 2017
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Augmented Versus Routine Approach to Giving Energy Trial Metabolic Effects Sub-study (TARGET-ME)
- ClinicalTrials.gov ID
- NCT03793244
- Acronym / sponsor ID
- TARGET-ME / MC_001 V1 240217
- Conditions
- Critical Illness, Enteral Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- The Canberra Hospital, Royal Adelaide Hospital, Auckland City Hospital, Melbourne Health
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 4 Jan 2019 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: TARGET protocol EN 1.5 kcal/mL | – | Dietary Supplement: TARGET protocol EN 1.5 kcal/mLEnteral (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients who are mechanically ventilated
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| TARGET protocol EN 1.5 kcal/mLEnteral nutrition | Dietary supplement | Experimental: TARGET protocol EN 1.5 kcal/mL |
Primary outcome
Calorie difference in kcal
Time frame: Up to day 28
Difference in mean calorie delivery and mean measured calorie utilisation over the study period (expressed as a percentage of measured requirements received) in each study group
1 secondary outcome
Calorie difference in kcal in the whole study cohort
Time frame: Up to day 28
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 2019.
- Individual participant dataSharing planned: No
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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?
An observational study of Critical Illness and Enteral Nutrition, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
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 7 inclusion and 5 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 2019. 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 Australia. 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?
Calorie difference in kcal (time frame: Up to day 28). 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 2019.