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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
Secondary ID [1] 0 0
ANZIC RC AD 003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Organ Failure 0 0
Critical Illness 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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

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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total energy amount delivered
Timepoint [1] 0 0
First 7 days of the study period

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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2016
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Geelong Hospital - Geelong
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
- Geelong
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Baxter Healthcare Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01847534
Trial related presentations / 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.
Ridley 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01847534