The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03292237




Registration number
NCT03292237
Ethics application status
Date submitted
11/09/2017
Date registered
25/09/2017
Date last updated
20/05/2020

Titles & IDs
Public title
Intensive Nutrition in Critically Ill Adults
Scientific title
Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial
Secondary ID [1] 0 0
ANZIC-RC/ER001
Universal Trial Number (UTN)
Trial acronym
INTENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Critically Ill 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Supplemental parenteral nutrition

No Intervention: Standard Nutrition Arm - In ICU:
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.
PN will only be used if the above methods have been attempted, or an absolute contraindication to EN develops.
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:
Nutrition management will be as per usual site management at that hospital.
Nutrition intake amounts will be recorded 3 times per week using provided study documents and assessment tools.

Experimental: Intensive Arm - Intervention
In ICU:
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
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
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.


Other interventions: Supplemental parenteral nutrition
Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total energy delivered - Total energy delivered from nutrition during the hospital admission
Timepoint [1] 0 0
Day 28
Secondary outcome [1] 0 0
Nutrition Outcomes - Protein delivery during hospital admission, Energy delivered during ICU admission, Energy delivery during the post-ICU period, Protein delivery during ICU admission, Protein delivery during the post-ICU period, Energy balance at ICU discharge, Energy balance at hospital discharge, Protein balance at hospital discharge, Protein balance at hospital discharge, Weight at hospital discharge
Timepoint [1] 0 0
Day 28
Secondary outcome [2] 0 0
Blood stream infections - Total blood stream infection rate, number of blood stream infections to day 28, time to any blood stream infection
Timepoint [2] 0 0
Hopsital admisiion
Secondary outcome [3] 0 0
Duration of mechanical ventilation - Duration of mechanical ventilation in survivors and non survivors
Timepoint [3] 0 0
Day 28
Secondary outcome [4] 0 0
Ventilator free days - Ventilator free days
Timepoint [4] 0 0
Day 28
Secondary outcome [5] 0 0
Renal replacement therapy - Renal replacement therapy
Timepoint [5] 0 0
Day 28
Secondary outcome [6] 0 0
Duration of ICU admission - Duration of ICU admission in survivors and non survivors
Timepoint [6] 0 0
Hospital admission
Secondary outcome [7] 0 0
Duration of hospital stay - Duration of hospital stay in survivors and non survivors
Timepoint [7] 0 0
Hospital admission
Secondary outcome [8] 0 0
In-hospital mortality - In-hospital mortality in survivors and non survivors
Timepoint [8] 0 0
Hospital admisison
Secondary outcome [9] 0 0
Frailty - Frailty at hospital admission and at 3 and 6 months using the Clinical Frailty Score
Timepoint [9] 0 0
Hospital admission and 3 and 6 moonth follow up
Secondary outcome [10] 0 0
Functional measures - Mobility scale (range 0-10) at ICU D/C, EQ5D-5L at 3 and 6 months, WHODAS at 3 and 6 months
Timepoint [10] 0 0
3 and 6 month follow up
Secondary outcome [11] 0 0
Days alive and at home - Follow- up outcomes
Timepoint [11] 0 0
3 and 6 months
Secondary outcome [12] 0 0
Cost effectiveness - Including resource utilisation
Timepoint [12] 0 0
3 and 6 month follow up

Eligibility
Key inclusion criteria
Inclusion criteria

Patients in intensive care who meet all of the following will be eligible:

1. Admitted to intensive care between 72 hours and 120 hours

2. Receiving invasive ventilator support

3. At least 18 years of age

4. Have central venous access suitable for PN solution administration

5. Have 1 or more organ system failure (respiratory, cardiovascular or renal) related to
their acute illness defined as:

- 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:

1. Noradrenaline = 0.1mcg/kg/min

2. Adrenaline = 0.1 mcg/kg/min

3. Any dose of vasopressin

4. Milrinone > 0.1 mcg/kg/min

- Renal dysfunction defined as:

1. Serum creatinine 2.0-2.9 times baseline OR

2. Urine output 0.5ml/kg/hr for = 12 hours OR

3. Currently receiving renal replacement therapy

- Currently has an intracranial pressure monitor or ventricular drain in situ
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

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

- 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

Study design
Purpose of the study
Supportive Care
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT,QLD,VIC
Recruitment hospital [1] 0 0
Royal Darwin Hospital - Darwin
Recruitment hospital [2] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [4] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [5] 0 0
Geelong Hospital - Geelong
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [8] 0 0
Epworth Richmond - Melbourne
Recruitment hospital [9] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [10] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
0810 - Darwin
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
4020 - Redcliffe
Recruitment postcode(s) [4] 0 0
3550 - Bendigo
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3010 - Melbourne
Recruitment postcode(s) [8] 0 0
3121 - Melbourne
Recruitment postcode(s) [9] 0 0
3128 - Melbourne
Recruitment postcode(s) [10] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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
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.
Trial website
https://clinicaltrials.gov/show/NCT03292237
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emma Ridley, PhD
Address 0 0
ANZIC-RC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Emma Ridley, PhD
Address 0 0
Country 0 0
Phone 0 0
+614399030350
Fax 0 0
Email 0 0
emma.ridley@monash.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03292237