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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01847534
Registration number
NCT01847534
Ethics application status
Date submitted
22/04/2013
Date registered
7/05/2013
Date last updated
2/08/2016
Titles & IDs
Public title
Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
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Scientific title
Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
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Secondary ID [1]
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ANZIC RC AD 003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Organ Failure
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Critical Illness
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Supplemental PN
Other interventions - Standard Care
Other: Standard Care - 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.
Experimental: Supplemental PN - Supplemental PN to complete inadequate EN provision
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.
EN will be managed as per local protocol however EN must not be reduced based on the supplemental PN being administered.
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.
Other interventions: Supplemental PN
Other interventions: Standard Care
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Total energy amount delivered
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Assessment method [1]
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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.
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Timepoint [1]
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First 7 days of the study period
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Eligibility
Key inclusion criteria
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:
1. Partial pressure of oxygen (PaO2) / Fraction of Inspired oxygen (FiO2) ratio =
300 mmHg
2. Currently on 1 or more continuous vasopressor infusion which were started at
least 4 hours ago at a minimum dose of :
1. Dopamine greater than 5 mcg/kg/min
2. Noradrenaline = 0.1mcg/kg/min
3. Adrenaline = 0.1 mcg/kg/min
4. Any dose of total vasopressin
5. Milrinone >0.25mcg/kg/min)
3. Renal dysfunction defined as
In patients without known renal disease:
1. serum creatinine > 171 mmol/l OR
2. Currently receiving renal replacement therapy
In patients with known renal disease:
3. an absolute increase of > 50% in creatinine from baseline OR
4. Currently receiving renal replacement therapy
4. Currently has an intracranial pressure monitor or ventricular drain in situ
5. Currently receiving extracorporeal membrane oxygenation
6. Currently has a ventricular assist device
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Supportive Care
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2016
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment hospital [2]
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Geelong Hospital - Geelong
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment postcode(s) [2]
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- Geelong
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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New Zealand
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State/province [3]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Baxter Healthcare Corporation
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01847534
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01847534
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