Multiple Organ FailurePhase 2/3NCT01847534
Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
A Phase 2/3 study testing Supplemental PN in people with Multiple Organ Failure and Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 6 sites in 2 countries.
Trial summary
One of the essential treatments for assisting patients in their recovery from illness is the provision of nutrition in a liquid form which is delivered into the stomach or as a fluid into the vein. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Multiple Organ Failure, Critical Illness
- What is being tested?
- Supplemental PN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Feb 2014to Jul 2016
- Phase
- Phase 2/3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients in intensive care who meet all of the following:
- Admitted to intensive care between 48 hours and 72 hours previously
- Mechanically ventilated at the time of enrollment and expected to remain ventilated until the day after tomorrow
- At least 16 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 23Show fewer
- Partial pressure of oxygen (PaO2) / Fraction of Inspired oxygen (FiO2) ratio ≤ 300 mmHg
- Currently on 1 or more continuous vasopressor infusion which were started at least 4 hours ago at a minimum dose of :
- Dopamine greater than 5 mcg/kg/min
- Noradrenaline ≥ 0.1mcg/kg/min
- Adrenaline ≥ 0.1 mcg/kg/min
- Any dose of total vasopressin
- Milrinone >0.25mcg/kg/min)
- Renal dysfunction defined as
- In patients without known renal disease:
- serum creatinine > 171 mmol/l OR
- Currently receiving renal replacement therapy
- In patients with known renal disease:
- an absolute increase of > 50% in creatinine from baseline OR
- Currently receiving renal replacement therapy
- Currently has an intracranial pressure monitor or ventricular drain in situ
- Currently receiving extracorporeal membrane oxygenation
- Currently has a ventricular assist device
Who cannot join
- Both EN and PN cannot be delivered at enrollment (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
- Standard PN solutions cannot be delivered at enrolment (i.e. clinicians believe that a patient definitely needs a specific parenteral nutrition formulation (e.g. glutamine-supplementation or specific lipid formulation).
- Death is imminent or deemed highly likely 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 illness
- More than 80% of energy requirements have been satisfactorily delivered via the enteral route in the last 24 hours.
- Are known to be pregnant
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
New Zealand4 sites
Auckland City Hospital (CVICU)
Auckland
Auckland City Hospital (DCCM)
Auckland
Christchurch Hospital
Christchurch
Wellington Hospital
Wellington
Australia2 sites
Geelong Hospital
Geelong
The Alfred Hospital
Melbourne, Victoria, 3004
About this study
One of the essential treatments for assisting patients in their recovery from illness is the provision of nutrition in a liquid form which is delivered into the stomach or as a fluid into the vein. Until recently the benefits of nutrition were undervalued in the critically ill, however, it has now become clear that targeted nutrition can positively affect a person's outcome. This is particularly important for patients who are significantly unwell and require increased amounts of nutrition to support recovery. Inadequate nutrition therapy leads them to rapidly lose weight, predominantly in the form of muscle loss which greatly contributes to their poor recovery.
Whilst nutrition is essential for recovery, there are several issues with the delivery of nutrition via the stomach (the most commonly used method of delivering nutrition in the critically ill). For many reasons, patients are unable to tolerate large quantities of nutrition via the stomach and in addition to this there are hospital or procedural reasons for nutrition being turned off for lengthy periods of time. As such, this results in patients being delivered only about half of the nutrition that is planned. One potential way to overcome this is to deliver nutrition via the vein, whilst nutrition into the stomach continues, with the aim to meet the energy gap that is lost by inadequate nutrition via the stomach.
In this study of 100 patients, we will deliver combined nutrition via the vein and stomach in 50 patients and the other 50 patients will receive nutrition as per normal practice. We will measure important outcomes for these patients to determine if this allows us to meet significantly more of their nutrition needs. This study will also help us determine how best to design a larger study of this strategy.
Read the detailed description
The principal objectives are:
- To determine whether the supplemental Parenteral Nutrition (PN) strategy leads to the delivery of increased amounts of total nutrition (measured as energy delivered), and is safe in regards to adverse effects.
- To measure the clinical outcomes in patients receiving both study strategies to provide information to assist design of a larger randomized controlled trial. Secondary objectives in a sub-set of patients are:
- To determine whether the supplemental PN strategy leads to improved nitrogen balance.
- To determine both the nutritional requirements and nutritional intake of critically ill patients during the period of hospitalization after transfer from the Intensive Care Unit (ICU).
- Conditions
- Multiple Organ Failure, Critical Illness
- Being tested
- Supplemental PN, Standard Care
- Medical subject headings
- Multiple Organ Failure, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental PNOther
Standard CareOther
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Other | Standard care: Nutrition will be managed as per best practice and local policy including the use of small bowel feeding tubes, prokinetics and PN if required to meet nutrition needs. Receives: Other: Standard Care |
| Supplemental PN | Experimental | Supplemental PN to complete inadequate EN provision
1. Patients allocated to the supplemental PN (intervention) group will have PN 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. EN will be managed as per local protocol however EN must not be reduced based on the supplemental PN being administered.
3. The adequacy of nutrition provision from both PN and EN will be assessed at midday each day for 7 days or until ICU discharge. The dose of PN will be adjusted according to a prespecified schedule. Receives: Other: Supplemental PN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy amount delivered
The primary outcome for this pilot study is the total energy amount delivered from nutrition therapy (ie. from Enteral Nutrition (EN) and from supplemental PN, if delivered) over the first 7 days of the study period.
Measured: First 7 days of the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startFeb 2014
- Primary completionJan 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple Organ FailureStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847534
- Sponsor's protocol ID
- ANZIC RC AD 003
- Status last verified
- Jul 2016
- First submitted
- 22 Apr 2013
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ridley EJ, Davies AR, Parke R, Bailey M, McArthur C, Gillanders L, Cooper DJ, McGuinness S; Supplemental Parenteral Nutrition Clinical Investigators. Supplemental parenteral nutrition versus usual care in critically ill adults: a pilot randomized controlled study. Crit Care. 2018 Jan 23;22(1):12. doi: 10.1186/s13054-018-1939-7.
PubMed 29361959Ridley EJ, Davies AR, Parke R, Bailey M, McArthur C, Gillanders L, Cooper DJ, McGuinness S; Supplemental Parenteral Nutrition Clinical Investigators. Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial. Trials. 2015 Dec 24;16:587. doi: 10.1186/s13063-015-1118-y.
PubMed 26703919
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01847534
- Acronym / sponsor ID
- ANZIC RC AD 003
- Conditions
- Multiple Organ Failure, Critical Illness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Feb 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 May 2013 (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.
One of the essential treatments for assisting patients in their recovery from illness is the provision of nutrition in a liquid form which is delivered into the stomach or as a fluid into the vein. Until recently the benefits of nutrition were undervalued in the critically ill, however, it has now become clear that targeted nutrition can positively affect a person's outcome. This is particularly important for patients who are significantly unwell and require increased amounts of nutrition to support recovery. Inadequate nutrition therapy leads them to rapidly lose weight, predominantly in the form of muscle loss which greatly contributes to their poor recovery.
Whilst nutrition is essential for recovery, there are several issues with the delivery of nutrition via the stomach (the most commonly used method of delivering nutrition in the critically ill). For many reasons, patients are unable to tolerate large quantities of nutrition via the stomach and in addition to this there are hospital or procedural reasons for nutrition being turned off for lengthy periods of time. As such, this results in patients being delivered only about half of the nutrition that is planned. One potential way to overcome this is to deliver nutrition via the vein, whilst nutrition into the stomach continues, with the aim to meet the energy gap that is lost by inadequate nutrition via the stomach.
In this study of 100 patients, we will deliver combined nutrition via the vein and stomach in 50 patients and the other 50 patients will receive nutrition as per normal practice. We will measure important outcomes for these patients to determine if this allows us to meet significantly more of their nutrition needs. This study will also help us determine how best to design a larger study of this strategy.
Detailed description
The principal objectives are:
- To determine whether the supplemental Parenteral Nutrition (PN) strategy leads to the delivery of increased amounts of total nutrition (measured as energy delivered), and is safe in regards to adverse effects.
- To measure the clinical outcomes in patients receiving both study strategies to provide information to assist design of a larger randomized controlled trial. Secondary objectives in a sub-set of patients are:
- To determine whether the supplemental PN strategy leads to improved nitrogen balance.
- To determine both the nutritional requirements and nutritional intake of critically ill patients during the period of hospitalization after transfer from the Intensive Care Unit (ICU).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Other | Other: Standard CareStandard care: Nutrition will be managed as per best practice and local policy including the use of small bowel feeding tubes, prokinetics and PN if required to meet nutrition needs. |
| Supplemental PN | Experimental | Other: Supplemental PNSupplemental PN to complete inadequate EN provision 1. Patients allocated to the supplemental PN (intervention) group will have PN 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. EN will be managed as per local protocol however EN must not be reduced based on the supplemental PN being administered. 3. The adequacy of nutrition provision from both PN and EN will be assessed at midday each day for 7 days or until ICU discharge. The dose of PN will be adjusted according to a prespecified schedule. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Admitted to intensive care between 48 hours and 72 hours previously
- Mechanically ventilated at the time of enrollment and expected to remain ventilated until the day after tomorrow
- At least 16 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 (7 listed)
- Both EN and PN cannot be delivered at enrollment (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
- Standard PN solutions cannot be delivered at enrolment (i.e. clinicians believe that a patient definitely needs a specific parenteral nutrition formulation (e.g. glutamine-supplementation or specific lipid formulation).
- Death is imminent or deemed highly likely 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 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 PN | Other | Supplemental PN |
| Standard Care | Other | Standard Care |
Primary outcome
Total energy amount delivered
Time frame: First 7 days of the study period
The primary outcome for this pilot study is the total energy amount delivered from nutrition therapy (ie. from Enteral Nutrition (EN) and from supplemental PN, if delivered) over the first 7 days of the study period.
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 2 Aug 2016.
- Derived from this study: PubMed 29361959Ridley EJ, Davies AR, Parke R, Bailey M, McArthur C, Gillanders L, Cooper DJ, McGuinness S; Supplemental Parenteral Nutrition Clinical Investigators. Supplemental parenteral nutrition versus usual care in critically ill adults: a pilot randomized controlled study. Crit Care. 2018 Jan 23;22(1):12. doi: 10.1186/s13054-018-1939-7.
- Derived from this study: PubMed 26703919Ridley EJ, Davies AR, Parke R, Bailey M, McArthur C, Gillanders L, Cooper DJ, McGuinness S; Supplemental Parenteral Nutrition Clinical Investigators. Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial. Trials. 2015 Dec 24;16:587. doi: 10.1186/s13063-015-1118-y.
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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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Supplemental PN in people with Multiple Organ Failure and Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 6 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 23 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 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in New Zealand, 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.
What does this combined 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.
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?
Total energy amount delivered (time frame: First 7 days of the study period). 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 NCT01847534, which also lists 2 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 2 Aug 2016.