Critical IllnessPhase 2INTENTNCT03292237
Intensive Nutrition in Critically Ill Adults
A Phase 2 study testing Supplemental parenteral nutrition in people with Critical Illness and Critically Ill, run by Australian and New Zealand Intensive Care Research Centre at 23 sites in 2 countries.
Trial summary
Despite the widespread use of nutrition therapy, no large scale randomized controlled trials (RCTs) have demonstrated positive outcomes with delivery of nutrition therapy early in critical illness, with some showing no effect with delayed nutrition or even harm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Critically Ill
- What is being tested?
- Supplemental parenteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 15 Oct 2018to 31 Jul 2023
- Phase
- Phase 2
- 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
- Patients in intensive care who meet all of the following will be eligible:
- Admitted to intensive care between 72 hours and 120 hours
- Receiving invasive ventilator support
- At least 18 years of age
- Have central venous access suitable for PN solution administration
- Have 1 or more organ system failure (respiratory, cardiovascular or renal) related to their acute illness defined as:
Show all 17Show fewer
- PaO2/FiO2 ≤ 300 mmHg
- Currently on 1 or more continuous inotrope/vasopressor infusion which were started at least 4 hours ago at a minimum dose of:
- Noradrenaline ≥ 0.1mcg/kg/min
- Adrenaline ≥ 0.1 mcg/kg/min
- Any dose of vasopressin
- Milrinone > 0.1 mcg/kg/min
- Renal dysfunction defined as:
- Serum creatinine 2.0-2.9 times baseline OR
- Urine output 0.5ml/kg/hr for ≥ 12 hours OR
- Currently receiving renal replacement therapy
- Currently has an intracranial pressure monitor or ventricular drain in situ
Who cannot join
- Patients will be excluded if:
- Both EN and PN cannot be delivered at enrolment (i.e. either an enteral tube or a central venous catheter cannot be placed or clinicians feel that EN or PN cannot be safely administered due to any other reason)
- Currently receiving PN
- Clinician believes a specific parenteral formula is indicated
- Death is imminent in the next 96 hours
- There is a current treatment limitation in place or the patient is unlikely to survive to 6 months due to underlying/chronic illness
Show all 11Show fewer
- More than 80% of energy requirements have been satisfactorily delivered via the enteral route in the last 24 hours
- Dialysis dependent chronic renal failure
- Suspected or known pregnancy
- Product contraindication
- The treating clinician does not believe the study to be in the best interest of the patient
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
Australia21 sites
Ballarat Hospital
Ballarat, Victoria, 3350
Bendigo Hospital
Bendigo, Victoria, 3550
Blacktown Hospital
Blacktown, New South Wales, 2148
Prince Charles Hospital
Brisbane, Queensland, 4032
Royal Darwin Hospital
Darwin, Northern Territory, 0810
Lyell McEwin
Elizabeth Vale, South Australia, 5112
Northern Hospital
Epping, Victoria, 3076
Frankston Hospital - Peninsula Health
Frankston, Victoria, 3199
Geelong Hospital
Geelong, Victoria, 3220
Austin Hospital
Heidelberg, Victoria, 3084
Nepean Hospital
Kingswood, New South Wales, 2747
The Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Melbourne, Victoria, 3010
Epworth Richmond
Melbourne, Victoria, 3121
Box Hill Hospital
Melbourne, Victoria, 3128
Monash Medical Centre
Melbourne, Victoria, 3168
Redcliffe Hospital
Redcliffe, Queensland, 4020
Mater Hospital
South Brisbane, Queensland, 4101
Gold Coast University Hospital
Southport, Queensland, 4215
Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand2 sites
Auckland City Hospital CVICU
Auckland, 1023
Middlemore Hospital
Auckland, 2025
About this study
Official title: Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial
Despite the widespread use of nutrition therapy, no large scale randomized controlled trials (RCTs) have demonstrated positive outcomes with delivery of nutrition therapy early in critical illness, with some showing no effect with delayed nutrition or even harm.
There are several possible reasons for the lack of observed benefit from RCTs to date; interventions have been short in duration (usually 3-10 days after intensive care unit (ICU) admission), perhaps applied at the incorrect time in regards to the patients metabolism and recovery, do not consider the patients nutrition risk, and have not addressed what happens to nutrition intake post ICU in critically ill individuals. This may explain why RCTs to date have not observed any positive associations with the delivery of nutrition; our focus to date may have been on the wrong stage of illness. A future study is thus urgently needed, which addresses the deficiencies in current RCTs by optimizing nutrition delivery for the whole hospital stay and collecting meaningful clinical, process and outcome data, which will potentially inform a larger trial of a similar nature.
This initial study aims to determine whether optimization of energy using a pre-tested supplemental parenteral nutrition (PN) strategy in the Intensive Care Unit (ICU) and an intensive nutrition intervention in the post ICU period will deliver more total energy than standard nutrition care during hospital admission in a group of critically ill patients with at least one organ system failure.
Read the detailed description
Background:
Nutrition is a commonly provided therapy in critical illness, but data about effectiveness is sparse. Best practice guidelines recommend enteral nutrition (EN), a specialised solution delivered into the gastrointestinal tract, as the first line of nutrition therapy. The majority of best practice guidelines also recommend delivery of energy and protein amounts close to predicted requirements in critical illness over the course of Intensive Care Unit (ICU) admission, however the only evidence to support this is from observational data. Although recommended that energy and protein requirements be met, and observational data suggests this is of benefit, there are practical challenges with the provision of EN. International practice surveys report the average energy and protein provided is approximately 59% of the patients predicted requirements, for multifactorial reasons. The addition of parenteral (intravenous) nutrition has been proposed as a method to provide additional energy when EN is insufficient, termed supplemental parenteral nutrition (PN). The ability of this strategy to deliver additional energy and protein to patients during critical illness has been proven in several feasibility/pilot trials, but the benefit on clinical and functional outcomes is unknown.
Despite observational data suggesting benefit when energy and protein delivery is optimised close to requirements, no large scale randomised controlled trials (RCTs) have confirmed improved clinical outcomes in critical illness, with some showing no effect with delayed nutrition or even harm. There are several possible reasons for the lack of observed benefit from RCTs to date; the interventions may have been applied at a time when the patient's metabolism is not in a phase of recovery; interventions have been short in duration and; studies have not addressed what happens to nutrition intake in the post ICU period of hospitalisation in critically ill individuals.
Aims:
To determine whether the use of a pre-tested supplemental PN strategy in the ICU and an intensive nutrition intervention after discharge to the hospital ward is feasible and will deliver more total energy than standard nutrition care over the entire hospital stay, in critically ill patients with at least one organ system failure.
A further aim is to develop a research program that will determine whether optimisation of energy to critically ill patients over the entire period of hospitalisation improves clinically-meaningful outcomes.
Hypothesis:
In critically ill patients with at least one organ failure, the use of a supplemental PN strategy in ICU and an intensive nutrition intervention on the hospital ward will lead to an increase in daily energy delivery of at least 15% over the entire hospital stay when compared to standard care.
Fifteen percent has been estimated as the minimum acceptable clinical difference between the two groups.
Objectives:
The major objectives are:
- To determine whether the whole hospital nutrition intervention leads to increased amounts of total energy delivered over the period of hospital stay
- To determine if the whole hospital nutrition intervention is safe in regards to adverse effects
- To determine if the post-ICU nutrition intervention is practically feasible when applied in multiple hospitals, across multiple wards
- To measure the clinical outcomes in patients and provide information to assist design of a larger randomised controlled trial
- Conditions
- Critical Illness, Critically Ill
- Being tested
- Supplemental parenteral nutrition
- Keywords
- Energy, Nutrition, Critical illness, Parenteral nutrition, Intensive care unit, Ward, Randomised Controlled Trial, Intensive Nutrition
- Medical subject headings
- Critical Illness, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental parenteral nutritionDietary supplement
Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
| Study group | Role | What they receive |
|---|---|---|
| Standard Nutrition Arm | No intervention | In ICU: 1. After enrolment, patients allocated to the standard nutrition therapy (control) group will commence or continue nutrition via an enteral tube to a target rate according to unit protocol including the use of promotility agents and the placement of nasojejunal feeding tubes if required. 2. PN will only be used if the above methods have been attempted, or an absolute contraindication to EN develops. 3. Unless there is specific indication for a compounded PN solution, the PN used in the standard care group will be the same as used in the intervention arm. After ICU: 1. Nutrition management will be as per usual site management at that hospital. 2. Nutrition intake amounts will be recorded 3 times per week using provided study documents and assessment tools. |
| Intensive Arm | Experimental | Intervention
In ICU:
1. Supplemental PN will be commenced within 2 hours of randomisation. The starting dose of PN will be determined by the amount of energy received in the 24 hours prior to randomisation
2. The need for the intervention will be based on the adequacy of nutrition provision from both PN and EN and assessed daily until ICU discharge
3. If there is an actual or anticipated interruption of EN for greater than 2 hours the PN must be run at 20 kcal/kg calculated body weight until EN is recommenced. After the interruption, EN should be recommenced as per local protocol.
After ICU:
An intensive nutrition intervention will be provided on the ward in the intervention group. This will include daily review from dedicated study dietitians and a clearly protocolized hierarchical management plan which reflects best practice clinical management. Receives: Dietary Supplement: Supplemental parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily energy delivered from nutrition therapy
Daily energy delivered from nutrition therapy
Measured: Day 28
Secondary outcomes (4)
Nutrition intake
Daily protein intake, Energy and protein intake by location (ICU and ward)
Measured: Day 28
Duration hospital stay
Duration of hospital stay in survivors and non-survivors
Measured: Day 28
Ventilator Free Days
Ventilator Free Days (VFDs) at study day 28
Measured: Day 28
Total blood stream infection rate
Total blood stream infection rate
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start15 Oct 2018
- Primary completion27 Feb 2023
- Study completion31 Jul 2023
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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre, prospective, parallel, randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Emma Ridley, PhD, Principal investigator, ANZIC-RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292237
- Sponsor's protocol ID
- ANZIC-RC/ER001
- Acronym
- INTENT
- Status last verified
- May 2024
- First submitted
- 11 Sep 2017
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing requests will be considered 2 years after publication of the primary trial data on an individual basis by the trial management committee (the data custodians). Data sharing will only be considered for investigator-initiated, independent researchers who provide a written data evaluation proposal that is judged to be methodologically sound. A data sharing agreement will be required to detail conditions under which data is shared and used. Resulting publications should appropriately cite and acknowledge the original data custodians. Requests for data sharing are to be made to anzicrc@monash.edu and the corresponding author, Dr Emma Ridley; emma.ridley@monash.edu
Publications
Ridley EJ, Bailey M, Chapman MJ, Chapple LS, Deane AM, Gojanovic M, Higgins AM, Hodgson CL, King VL, Marshall AP, Miller EG, McGuinness SP, Parke RL, Paul E, Udy AA; Australian, New Zealand Intensive Care Society Clinical Trials Group. The impact of a tailored nutrition intervention delivered for the duration of hospitalisation on daily energy delivery for patients with critical illness (INTENT): a phase II randomised controlled trial. Crit Care. 2025 Jan 6;29(1):8. doi: 10.1186/s13054-024-05189-3.
PubMed 39762887Ridley EJ, Bailey M, Chapman M, Chapple LS, Deane AM, Hodgson C, King VL, Marshall A, Miller EG, McGuinness SP, Parke R, Udy AA; the Australian and New Zealand Intensive Care Society Clinical Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group. Protocol summary and statistical analysis plan for Intensive Nutrition Therapy comparEd to usual care iN criTically ill adults (INTENT): a phase II randomised controlled trial. BMJ Open. 2022 Mar 8;12(3):e050153. doi: 10.1136/bmjopen-2021-050153.
PubMed 35260448Ridley EJ. Parenteral nutrition in critical illness: total, supplemental or never? Curr Opin Clin Nutr Metab Care. 2021 Mar 1;24(2):176-182. doi: 10.1097/MCO.0000000000000719.
PubMed 33315720Ridley EJ, Parke RL, Davies AR, Bailey M, Hodgson C, Deane AM, McGuinness S, Cooper DJ. What Happens to Nutrition Intake in the Post-Intensive Care Unit Hospitalization Period? An Observational Cohort Study in Critically Ill Adults. JPEN J Parenter Enteral Nutr. 2019 Jan;43(1):88-95. doi: 10.1002/jpen.1196. Epub 2018 Jun 20.
PubMed 29924393
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial
- ClinicalTrials.gov ID
- NCT03292237
- Acronym / sponsor ID
- INTENT / ANZIC-RC/ER001
- Conditions
- Critical Illness, Critically Ill
- Keywords
- Energy, Nutrition, Critical illness, Parenteral nutrition, Intensive care unit, Ward, Randomised Controlled Trial, Intensive Nutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 25 Sep 2017 (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.
Despite the widespread use of nutrition therapy, no large scale randomized controlled trials (RCTs) have demonstrated positive outcomes with delivery of nutrition therapy early in critical illness, with some showing no effect with delayed nutrition or even harm.
There are several possible reasons for the lack of observed benefit from RCTs to date; interventions have been short in duration (usually 3-10 days after intensive care unit (ICU) admission), perhaps applied at the incorrect time in regards to the patients metabolism and recovery, do not consider the patients nutrition risk, and have not addressed what happens to nutrition intake post ICU in critically ill individuals. This may explain why RCTs to date have not observed any positive associations with the delivery of nutrition; our focus to date may have been on the wrong stage of illness. A future study is thus urgently needed, which addresses the deficiencies in current RCTs by optimizing nutrition delivery for the whole hospital stay and collecting meaningful clinical, process and outcome data, which will potentially inform a larger trial of a similar nature.
This initial study aims to determine whether optimization of energy using a pre-tested supplemental parenteral nutrition (PN) strategy in the Intensive Care Unit (ICU) and an intensive nutrition intervention in the post ICU period will deliver more total energy than standard nutrition care during hospital admission in a group of critically ill patients with at least one organ system failure.
Detailed description
Background:
Nutrition is a commonly provided therapy in critical illness, but data about effectiveness is sparse. Best practice guidelines recommend enteral nutrition (EN), a specialised solution delivered into the gastrointestinal tract, as the first line of nutrition therapy. The majority of best practice guidelines also recommend delivery of energy and protein amounts close to predicted requirements in critical illness over the course of Intensive Care Unit (ICU) admission, however the only evidence to support this is from observational data. Although recommended that energy and protein requirements be met, and observational data suggests this is of benefit, there are practical challenges with the provision of EN. International practice surveys report the average energy and protein provided is approximately 59% of the patients predicted requirements, for multifactorial reasons. The addition of parenteral (intravenous) nutrition has been proposed as a method to provide additional energy when EN is insufficient, termed supplemental parenteral nutrition (PN). The ability of this strategy to deliver additional energy and protein to patients during critical illness has been proven in several feasibility/pilot trials, but the benefit on clinical and functional outcomes is unknown.
Despite observational data suggesting benefit when energy and protein delivery is optimised close to requirements, no large scale randomised controlled trials (RCTs) have confirmed improved clinical outcomes in critical illness, with some showing no effect with delayed nutrition or even harm. There are several possible reasons for the lack of observed benefit from RCTs to date; the interventions may have been applied at a time when the patient's metabolism is not in a phase of recovery; interventions have been short in duration and; studies have not addressed what happens to nutrition intake in the post ICU period of hospitalisation in critically ill individuals.
Aims:
To determine whether the use of a pre-tested supplemental PN strategy in the ICU and an intensive nutrition intervention after discharge to the hospital ward is feasible and will deliver more total energy than standard nutrition care over the entire hospital stay, in critically ill patients with at least one organ system failure.
A further aim is to develop a research program that will determine whether optimisation of energy to critically ill patients over the entire period of hospitalisation improves clinically-meaningful outcomes.
Hypothesis:
In critically ill patients with at least one organ failure, the use of a supplemental PN strategy in ICU and an intensive nutrition intervention on the hospital ward will lead to an increase in daily energy delivery of at least 15% over the entire hospital stay when compared to standard care.
Fifteen percent has been estimated as the minimum acceptable clinical difference between the two groups.
Objectives:
The major objectives are:
- To determine whether the whole hospital nutrition intervention leads to increased amounts of total energy delivered over the period of hospital stay
- To determine if the whole hospital nutrition intervention is safe in regards to adverse effects
- To determine if the post-ICU nutrition intervention is practically feasible when applied in multiple hospitals, across multiple wards
- To measure the clinical outcomes in patients and provide information to assist design of a larger randomised controlled trial
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicentre, prospective, parallel, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard Nutrition Arm | No intervention | –In ICU: 1. After enrolment, patients allocated to the standard nutrition therapy (control) group will commence or continue nutrition via an enteral tube to a target rate according to unit protocol including the use of promotility agents and the placement of nasojejunal feeding tubes if required. 2. PN will only be used if the above methods have been attempted, or an absolute contraindication to EN develops. 3. Unless there is specific indication for a compounded PN solution, the PN used in the standard care group will be the same as used in the intervention arm. After ICU: 1. Nutrition management will be as per usual site management at that hospital. 2. Nutrition intake amounts will be recorded 3 times per week using provided study documents and assessment tools. |
| Intensive Arm | Experimental | Dietary Supplement: Supplemental parenteral nutritionIntervention In ICU: 1. Supplemental PN will be commenced within 2 hours of randomisation. The starting dose of PN will be determined by the amount of energy received in the 24 hours prior to randomisation 2. The need for the intervention will be based on the adequacy of nutrition provision from both PN and EN and assessed daily until ICU discharge 3. If there is an actual or anticipated interruption of EN for greater than 2 hours the PN must be run at 20 kcal/kg calculated body weight until EN is recommenced. After the interruption, EN should be recommenced as per local protocol. After ICU: An intensive nutrition intervention will be provided on the ward in the intervention group. This will include daily review from dedicated study dietitians and a clearly protocolized hierarchical management plan which reflects best practice clinical management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Admitted to intensive care between 72 hours and 120 hours
- Receiving invasive ventilator support
- At least 18 years of age
- Have central venous access suitable for PN solution administration
- Have 1 or more organ system failure (respiratory, cardiovascular or renal) related to their acute illness defined as:
Key exclusion criteria (11 listed)
- Both EN and PN cannot be delivered at enrolment (i.e. either an enteral tube or a central venous catheter cannot be placed or clinicians feel that EN or PN cannot be safely administered due to any other reason)
- Currently receiving PN
- Clinician believes a specific parenteral formula is indicated
- Death is imminent in the next 96 hours
- There is a current treatment limitation in place or the patient is unlikely to survive to 6 months due to underlying/chronic illness
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 |
|---|---|---|
| Supplemental parenteral nutritionSupplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation) | Dietary supplement | Intensive Arm |
Primary outcome
Daily energy delivered from nutrition therapy
Time frame: Day 28
Daily energy delivered from nutrition therapy
4 secondary outcomes
Nutrition intake
Time frame: Day 28
Duration hospital stay
Time frame: Day 28
Ventilator Free Days
Time frame: Day 28
Total blood stream infection rate
Time frame: 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 24 May 2024.
- Derived from this study: PubMed 39762887Ridley EJ, Bailey M, Chapman MJ, Chapple LS, Deane AM, Gojanovic M, Higgins AM, Hodgson CL, King VL, Marshall AP, Miller EG, McGuinness SP, Parke RL, Paul E, Udy AA; Australian, New Zealand Intensive Care Society Clinical Trials Group. The impact of a tailored nutrition intervention delivered for the duration of hospitalisation on daily energy delivery for patients with critical illness (INTENT): a phase II randomised controlled trial. Crit Care. 2025 Jan 6;29(1):8. doi: 10.1186/s13054-024-05189-3.
- Derived from this study: PubMed 35260448Ridley EJ, Bailey M, Chapman M, Chapple LS, Deane AM, Hodgson C, King VL, Marshall A, Miller EG, McGuinness SP, Parke R, Udy AA; the Australian and New Zealand Intensive Care Society Clinical Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group. Protocol summary and statistical analysis plan for Intensive Nutrition Therapy comparEd to usual care iN criTically ill adults (INTENT): a phase II randomised controlled trial. BMJ Open. 2022 Mar 8;12(3):e050153. doi: 10.1136/bmjopen-2021-050153.
- Derived from this study: PubMed 33315720Ridley EJ. Parenteral nutrition in critical illness: total, supplemental or never? Curr Opin Clin Nutr Metab Care. 2021 Mar 1;24(2):176-182. doi: 10.1097/MCO.0000000000000719.
- Derived from this study: PubMed 29924393Ridley EJ, Parke RL, Davies AR, Bailey M, Hodgson C, Deane AM, McGuinness S, Cooper DJ. What Happens to Nutrition Intake in the Post-Intensive Care Unit Hospitalization Period? An Observational Cohort Study in Critically Ill Adults. JPEN J Parenter Enteral Nutr. 2019 Jan;43(1):88-95. doi: 10.1002/jpen.1196. Epub 2018 Jun 20.
- Individual participant dataSharing planned: Yes. Data sharing requests will be considered 2 years after publication of the primary trial data on an individual basis by the trial management committee (the data custodians). Data sharing will only be considered for investigator-initiated, independent researchers who provide a written data evaluation proposal that is judged to be methodologically sound. A data sharing agreement will be required to detail conditions under which data is shared and used. Resulting publications should appropriately cite and acknowledge the original data custodians. Requests for data sharing are to be made to anzicrc@monash.edu and the corresponding author, Dr Emma Ridley; emma.ridley@monash.edu
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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.
Emma Ridley, PhD principal investigator
ANZIC-RC
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Supplemental parenteral nutrition in people with Critical Illness and Critically Ill, run by Australian and New Zealand Intensive Care Research Centre at 23 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 17 inclusion and 11 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 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Daily energy delivered from nutrition therapy (time frame: Day 28). 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 NCT03292237, 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 24 May 2024; AzTrials last refreshed its copy on 2 Nov 2026.