Critical IllnessPhase 3TARGETNCT02306746
The Augmented Versus Routine Approach to Giving Energy Trial
A Phase 3 study testing TARGET protocol EN 1.5 kcal/mL and TARGET protocol EN 1.0 kcal/mL in people with Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 46 sites in 2 countries.
Trial summary
Nutrition therapy is an essential standard of care for all critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- TARGET protocol EN 1.5 kcal/mL and TARGET protocol EN 1.0 kcal/mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 16 Jun 2016to 1 Aug 2018
- Phase
- Phase 3
- 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
Who may be able to join
- Intubated and receiving mechanical ventilation
- About to commence enteral nutrition or enteral nutrition commenced within the previous12 hours
- Expected to be receiving enteral nutrition in ICU until at least the day after tomorrow
Who cannot join
- Any Enteral Nutrition (EN) or Parenteral Nutrition (PN) received for >12 hours in this ICU admission
- Treating clinician considers the EN goal rate (i.e.1ml/kg of ideal body weight per hour) to be clinically contraindicated e.g. requirement for fluid restriction
- Requirement for specific nutritional therapy as determined by the treating doctor or dietitian i.e. TARGET protocol EN not considered to be in the best interest of the patient
- Death is deemed to be imminent or inevitable during this admission and either the attending physician, patient or substitute decision maker is not committed to active treatment
- The patient has an underlying disease that makes survival to 90 days unlikely
- ≥ 15% burns
- Previously enrolled in this study
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
Australia34 sites
Royal Adelaide Hosptial
Adelaide, South Australia, 5000
Queen Elizabeth Hospital
Adelaide, South Australia, 5011
Lyell McEwin
Adelaide, South Australia, 5112
Bendigo Hospital
Bendigo, Victoria, 3550
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Logan Hospital
Brisbane, Queensland, 4131
Bunbury Hospital
Bunbury, Western Australia, 6230
Canberra Hospital
Canberra, Australian Capital Territory, 2605
Footscray Hospital
Footscray, Victoria, 3011
Frankston Hosptial
Frankston, Victoria, 3199
University Hosptial Geelong
Geelong, Victoria, 3220
Gosford Hospital
Gosford, New South Wales, 2250
Austin Hospital
Heidelberg, Victoria, 3084
Royal Hobart Hospital
Hobart, Tasmania, 7000
Launceston General Hospital
Launceston, Tasmania, 7250
Sunshine Hospital
Melbourne, Victoria, 3021
Royal Melbourne Hospital
Melbourne, Victoria, 3050
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
Monash Health Dandenong Hospital
Melbourne, Victoria, 3175
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Fiona Stanley Hospital
Perth, Western Australia, 6150
St John of God Hospital Murdoch
Perth, Western Australia, 6150
St Vincent's Hospital Sydney
Sydney, New South Wales, 2010
Royal North Shore Hosptial
Sydney, New South Wales, 2065
Sydney Adventist Hospital
Sydney, New South Wales, 2076
Concord Hospital
Sydney, New South Wales, 2139
Westmead Hospital
Sydney, New South Wales, 2145
Blacktown Hospital
Sydney, New South Wales, 2148
Liverpool Hospital
Sydney, New South Wales, 2170
St George Hospital
Sydney, New South Wales, 2217
Nepean Hospital
Sydney, New South Wales, 2747
Royal Prince Alfred Hospital
Sydney, New South Wales
Toowoomba Hospital
Toowoomba, Queensland, 4350
New Zealand12 sites
North Shore Hospital
Auckland, 0622
Auckland City Hospital Cardiovascular Intensive Care Unit
Auckland, 1023
Auckland City Hospital Department of Critical Care Medicine
Auckland, 1023
Middlemore Hospital
Auckland, 2025
Christchurch Hospital
Christchurch, 4710
Waikato Hospital
Hamilton, 3204
Hawkes Bay Fallen Soldiers Memorial Hospital
Hastings, 4156
Hutt Valley Hospital
Lower Hutt, 5010
Nelson Hospital
Nelson, 7010
Rotorua Hospital
Rotorua, 3010
Tauranga Hospital
Tauranga, 3112
Wellington Regional Hospital
Wellington, 6021
About this study
Official title: The Augmented Versus Routine Approach to Giving Energy Trial: A Randomised Controlled Trial
Nutrition therapy is an essential standard of care for all critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days.
The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial to determine if augmentation of calorie delivery using energy dense enteral nutrition in mechanically ventilated patients improves 90 day survival when compared to routine care.
Read the detailed description
Each year around 130,000 Australians are admitted to ICU at a daily cost of approximately $4000 per patient. Their care consumes close to 3 billion dollars per year. These critically ill patients are the sickest in the hospital. They require substantial resources and multiple interventions. Some die and many of those who survive have delayed and compromised functional recovery which can persist for months or years.
Nutrition therapy is an essential standard of care for all ICU patients who are mechanically ventilated and remain in ICU for more than a few days. Enteral nutrition (via a nasogastric tube) is usually initiated within 24 hours of ICU admission with a formula containing 1 kcal/ml and prescribed at an approximate rate of 1 ml/kg/hour. However, standard enteral nutrition practice typically results in the delivery of only ~60% of the full-recommended calorie requirement.
Although prescribed calories can reliably be delivered using the intravenous route, the enteral route is preferred for a number of reasons and is recommended by all nutrition guidelines as first-line therapy. In particular, enteral nutrition is more physiological, less costly and associated with fewer infective complications. Delivery of nutrient into the gut also has beneficial effects on subsequent gut function and may reduce ongoing sepsis which can be fuelled by the movement of gut flora through a permeable mucosa that has not been exposed to nutrient. Intravenous nutrition is accordingly, generally used only when enteral feeding is impossible, or persistently limited. Although supplementing enteral with intravenous nutrition can increase calorie delivery, this has not been shown to have a therapeutic benefit and may worsen important clinical outcomes. This may be because adverse effects associated with intravenous nutrition counteract the benefits of increased calorie delivery.
Previous trials support the concept that optimising nutrition in the critically ill will improve outcome, however, the evidence is limited, inclusive and generally of low quality. It is extraordinary that there is not better (Level I) evidence to inform nutrition management in critically ill patients given the frequency of the intervention, the biologic rationale, the high mortality following ICU admission, the frequency of muscle wasting and the poor functional outcomes in survivors. This is especially true given the low cost of enteral nutrition (~$23/day).
The investigators recently completed pilot study clearly achieved all the key criteria which, for a pharmaceutical product, would lead to a phase III trial, namely: 1. feasibility; 2. safety; 3. separation; 4. excellent recruitment rate; 5. successful blinding; 6. a signal for benefit.
A definitive study must now be done to establish whether 90-day survival and functional outcomes following critical illness may be improved by increased calorie delivery.
- Conditions
- Critical Illness
- Being tested
- TARGET protocol EN 1.5 kcal/mL, TARGET protocol EN 1.0 kcal/mL
- Keywords
- Enteral nutrition, randomised control trial, Critical care, Outcome
- 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 feed 1.5 kcal/mL
TARGET protocol EN 1.0 kcal/mLDietary supplement
Enteral feed 1.0 kcal/mL
| Study group | Role | What they receive |
|---|---|---|
| TARGET protocol EN 1.5 kcal/mL | Experimental | Enteral (EN) feed 1.5 kcal/mL. The goal rate for administration of TARGET protocol EN is 1ml/kg/hr. To calculate the goal rate, weight is based on ideal body weight. Receives: Dietary Supplement: TARGET protocol EN 1.5 kcal/mL |
| TARGET protocol EN 1.0 kcal/mL | Active comparator | Enteral feed 1.0 kcal/mL The goal rate for administration of TARGET protocol EN is 1ml/kg/hr. To calculate the goal rate, weight is based on ideal body weight. Receives: Dietary Supplement: TARGET protocol EN 1.0 kcal/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Mortality status
Measured: Day 90
Secondary outcomes (18)
Mortality
Mortality status
Measured: At hospital discharge an average of 28 days
Mortality
Mortality status
Measured: Day 28
Time from randomisation until death
Mortality status
Measured: Day 180
Number of days alive and not in ICU
Mortality status
Measured: Day 28
Number of days alive and not in hospital
Mortality status
Measured: Day 28
Ventilator free days
Organ support status
Measured: Day 28
Proportion of patients receiving vasopressor support
Organ support proportion
Measured: Day 28
Vasopressor free days
Organ support status
Measured: Day 28
Proportion of patients receiving any renal replacement therapy
Organ support proportion
Measured: Day 28
Renal replacement therapy free days
Organ support status
Measured: Day 28
Proportion of patients with positive blood cultures
Blood stream infection proportion
Measured: Day 28
Proportion of patients requiring intravenous antimicrobials
Patients requiring intravenous antimicrobials
Measured: Day 28
Mortality
Mortality status
Measured: Day 180
Quality of life assessment
European Quality of Life 5 Dimensions
Measured: Day 180
Functional outcomes for patients under 65 years in the work force
Questions from the Australian Labour Force Survey
Measured: Day 180
Functional outcomes for patients under 65 years and not in the work force and patients 65 years and over living dependently
World Health Organization Disability Assessment Schedule 2.0
Measured: Day 180
Functional outcomes for patients 65 years and over living independently
Adelaide Activities Profile
Measured: Day 180
Cause-specific mortality
Mortality status
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study start16 Jun 2016
- 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.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Peake, MD, Study chair, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306746
- Sponsor's protocol ID
- ANZIC-RC/MC001
- Acronym
- TARGET
- Status last verified
- Sep 2018
- First submitted
- 11 Nov 2014
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Peake SL, Lange K, Van Mourik N, Ridley EJ, Williams PJ, Chapman M; TARGET Investigators. The relationship between obesity, calorie delivery and mortality in the critically ill: a post hoc analysis of The Augmented versus Routine Approach to Giving Energy Trial. Am J Clin Nutr. 2026 Mar;123(3):101206. doi: 10.1016/j.ajcnut.2026.101206. Epub 2026 Feb 16.
PubMed 41781080Wittholz K, Fetterplace K, Chapple LA, Ridley EJ, Finnis M, Presneill J, Chapman M, Peake S, Bellomo R, Karahalios A, Deane AM. Six-month outcomes after traumatic brain injury in the Augmented versus Routine Approach to Giving Energy multicentre, double-blind, randomised controlled Trial (TARGET). Aust Crit Care. 2025 Mar;38(2):101116. doi: 10.1016/j.aucc.2024.09.001. Epub 2024 Oct 10.
PubMed 39389845Arunachala Murthy T, Chapple LS, Lange K, Marathe CS, Horowitz M, Peake SL, Chapman MJ. Gastrointestinal dysfunction during enteral nutrition delivery in intensive care unit (ICU) patients: Risk factors, natural history, and clinical implications. A post-hoc analysis of The Augmented versus Routine approach to Giving Energy Trial (TARGET). Am J Clin Nutr. 2022 Aug 4;116(2):589-598. doi: 10.1093/ajcn/nqac113.
PubMed 35472097TARGET Investigators, for the ANZICS Clinical Trials Group; Chapman M, Peake SL, Bellomo R, Davies A, Deane A, Horowitz M, Hurford S, Lange K, Little L, Mackle D, O'Connor S, Presneill J, Ridley E, Williams P, Young P. Energy-Dense versus Routine Enteral Nutrition in the Critically Ill. N Engl J Med. 2018 Nov 8;379(19):1823-1834. doi: 10.1056/NEJMoa1811687. Epub 2018 Oct 22.
PubMed 30346225
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Augmented Versus Routine Approach to Giving Energy Trial: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02306746
- Acronym / sponsor ID
- TARGET / ANZIC-RC/MC001
- Conditions
- Critical Illness
- Keywords
- Enteral nutrition, randomised control trial, Critical care, Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 3 Dec 2014 (estimated)
- 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.
Nutrition therapy is an essential standard of care for all critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days.
The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial to determine if augmentation of calorie delivery using energy dense enteral nutrition in mechanically ventilated patients improves 90 day survival when compared to routine care.
Detailed description
Each year around 130,000 Australians are admitted to ICU at a daily cost of approximately $4000 per patient. Their care consumes close to 3 billion dollars per year. These critically ill patients are the sickest in the hospital. They require substantial resources and multiple interventions. Some die and many of those who survive have delayed and compromised functional recovery which can persist for months or years.
Nutrition therapy is an essential standard of care for all ICU patients who are mechanically ventilated and remain in ICU for more than a few days. Enteral nutrition (via a nasogastric tube) is usually initiated within 24 hours of ICU admission with a formula containing 1 kcal/ml and prescribed at an approximate rate of 1 ml/kg/hour. However, standard enteral nutrition practice typically results in the delivery of only ~60% of the full-recommended calorie requirement.
Although prescribed calories can reliably be delivered using the intravenous route, the enteral route is preferred for a number of reasons and is recommended by all nutrition guidelines as first-line therapy. In particular, enteral nutrition is more physiological, less costly and associated with fewer infective complications. Delivery of nutrient into the gut also has beneficial effects on subsequent gut function and may reduce ongoing sepsis which can be fuelled by the movement of gut flora through a permeable mucosa that has not been exposed to nutrient. Intravenous nutrition is accordingly, generally used only when enteral feeding is impossible, or persistently limited. Although supplementing enteral with intravenous nutrition can increase calorie delivery, this has not been shown to have a therapeutic benefit and may worsen important clinical outcomes. This may be because adverse effects associated with intravenous nutrition counteract the benefits of increased calorie delivery.
Previous trials support the concept that optimising nutrition in the critically ill will improve outcome, however, the evidence is limited, inclusive and generally of low quality. It is extraordinary that there is not better (Level I) evidence to inform nutrition management in critically ill patients given the frequency of the intervention, the biologic rationale, the high mortality following ICU admission, the frequency of muscle wasting and the poor functional outcomes in survivors. This is especially true given the low cost of enteral nutrition (~$23/day).
The investigators recently completed pilot study clearly achieved all the key criteria which, for a pharmaceutical product, would lead to a phase III trial, namely: 1. feasibility; 2. safety; 3. separation; 4. excellent recruitment rate; 5. successful blinding; 6. a signal for benefit.
A definitive study must now be done to establish whether 90-day survival and functional outcomes following critical illness may be improved by increased calorie delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TARGET protocol EN 1.5 kcal/mL | Experimental | Dietary Supplement: TARGET protocol EN 1.5 kcal/mLEnteral (EN) feed 1.5 kcal/mL. The goal rate for administration of TARGET protocol EN is 1ml/kg/hr. To calculate the goal rate, weight is based on ideal body weight. |
| TARGET protocol EN 1.0 kcal/mL | Active comparator | Dietary Supplement: TARGET protocol EN 1.0 kcal/mLEnteral feed 1.0 kcal/mL The goal rate for administration of TARGET protocol EN is 1ml/kg/hr. To calculate the goal rate, weight is based on ideal body weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intubated and receiving mechanical ventilation
- About to commence enteral nutrition or enteral nutrition commenced within the previous12 hours
- Expected to be receiving enteral nutrition in ICU until at least the day after tomorrow
Key exclusion criteria (7 listed)
- Any Enteral Nutrition (EN) or Parenteral Nutrition (PN) received for >12 hours in this ICU admission
- Treating clinician considers the EN goal rate (i.e.1ml/kg of ideal body weight per hour) to be clinically contraindicated e.g. requirement for fluid restriction
- Requirement for specific nutritional therapy as determined by the treating doctor or dietitian i.e. TARGET protocol EN not considered to be in the best interest of the patient
- Death is deemed to be imminent or inevitable during this admission and either the attending physician, patient or substitute decision maker is not committed to active treatment
- The patient has an underlying disease that makes survival to 90 days unlikely
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 feed 1.5 kcal/mL | Dietary supplement | TARGET protocol EN 1.5 kcal/mL |
| TARGET protocol EN 1.0 kcal/mLEnteral feed 1.0 kcal/mL | Dietary supplement | TARGET protocol EN 1.0 kcal/mL |
Primary outcome
All cause mortality
Time frame: Day 90
Mortality status
18 secondary outcomes
Mortality
Time frame: At hospital discharge an average of 28 days
Mortality
Time frame: Day 28
Time from randomisation until death
Time frame: Day 180
Number of days alive and not in ICU
Time frame: Day 28
Number of days alive and not in hospital
Time frame: Day 28
Ventilator free days
Time frame: Day 28
Proportion of patients receiving vasopressor support
Time frame: Day 28
Vasopressor free days
Time frame: Day 28
Proportion of patients receiving any renal replacement therapy
Time frame: Day 28
Renal replacement therapy free days
Time frame: Day 28
Proportion of patients with positive blood cultures
Time frame: Day 28
Proportion of patients requiring intravenous antimicrobials
Time frame: Day 28
Mortality
Time frame: Day 180
Quality of life assessment
Time frame: Day 180
Functional outcomes for patients under 65 years in the work force
Time frame: Day 180
Functional outcomes for patients under 65 years and not in the work force and patients 65 years and over living dependently
Time frame: Day 180
Functional outcomes for patients 65 years and over living independently
Time frame: Day 180
Cause-specific mortality
Time frame: Day 90
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 13 Sep 2018.
- Derived from this study: PubMed 41781080Peake SL, Lange K, Van Mourik N, Ridley EJ, Williams PJ, Chapman M; TARGET Investigators. The relationship between obesity, calorie delivery and mortality in the critically ill: a post hoc analysis of The Augmented versus Routine Approach to Giving Energy Trial. Am J Clin Nutr. 2026 Mar;123(3):101206. doi: 10.1016/j.ajcnut.2026.101206. Epub 2026 Feb 16.
- Derived from this study: PubMed 39389845Wittholz K, Fetterplace K, Chapple LA, Ridley EJ, Finnis M, Presneill J, Chapman M, Peake S, Bellomo R, Karahalios A, Deane AM. Six-month outcomes after traumatic brain injury in the Augmented versus Routine Approach to Giving Energy multicentre, double-blind, randomised controlled Trial (TARGET). Aust Crit Care. 2025 Mar;38(2):101116. doi: 10.1016/j.aucc.2024.09.001. Epub 2024 Oct 10.
- Derived from this study: PubMed 35472097Arunachala Murthy T, Chapple LS, Lange K, Marathe CS, Horowitz M, Peake SL, Chapman MJ. Gastrointestinal dysfunction during enteral nutrition delivery in intensive care unit (ICU) patients: Risk factors, natural history, and clinical implications. A post-hoc analysis of The Augmented versus Routine approach to Giving Energy Trial (TARGET). Am J Clin Nutr. 2022 Aug 4;116(2):589-598. doi: 10.1093/ajcn/nqac113.
- Derived from this study: PubMed 30346225TARGET Investigators, for the ANZICS Clinical Trials Group; Chapman M, Peake SL, Bellomo R, Davies A, Deane A, Horowitz M, Hurford S, Lange K, Little L, Mackle D, O'Connor S, Presneill J, Ridley E, Williams P, Young P. Energy-Dense versus Routine Enteral Nutrition in the Critically Ill. N Engl J Med. 2018 Nov 8;379(19):1823-1834. doi: 10.1056/NEJMoa1811687. Epub 2018 Oct 22.
- Statistical analysis plan publication, March 2018Link provided by the sponsor.
- Protocol publication, March 2018Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sandra Peake, MD study chair
University of Adelaide
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TARGET protocol EN 1.5 kcal/mL and TARGET protocol EN 1.0 kcal/mL in people with Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 46 sites in 2 countries.
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 7 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Australia, New Zealand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
All cause mortality (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306746, which also lists 4 linked publications.
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 13 Sep 2018.