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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03292237
Ethics application status
Date submitted
11/09/2017
Date registered
25/09/2017
Date last updated
24/05/2024

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
Treatment: Other - Supplemental parenteral nutrition

No intervention: Standard Nutrition Arm - 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.

Experimental: Intensive Arm - 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.


Treatment: Other: Supplemental parenteral nutrition
Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Daily energy delivered from nutrition therapy
Timepoint [1] 0 0
Day 28
Secondary outcome [1] 0 0
Nutrition intake
Timepoint [1] 0 0
Day 28
Secondary outcome [2] 0 0
Duration hospital stay
Timepoint [2] 0 0
Day 28
Secondary outcome [3] 0 0
Ventilator Free Days
Timepoint [3] 0 0
Day 28
Secondary outcome [4] 0 0
Total blood stream infection rate
Timepoint [4] 0 0
Day 28

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
Sex
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
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
15/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2023
Sample size
Target
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Royal Darwin Hospital - Darwin
Recruitment hospital [4] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [5] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [6] 0 0
Mater Hospital - South Brisbane
Recruitment hospital [7] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Lyell McEwin - Elizabeth Vale
Recruitment hospital [10] 0 0
Queen Elizabeth Hospital - Woodville South
Recruitment hospital [11] 0 0
Ballarat Hospital - Ballarat
Recruitment hospital [12] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [13] 0 0
Northern Hospital - Epping
Recruitment hospital [14] 0 0
Frankston Hospital - Peninsula Health - Frankston
Recruitment hospital [15] 0 0
Geelong Hospital - Geelong
Recruitment hospital [16] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [17] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [18] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [19] 0 0
Epworth Richmond - Melbourne
Recruitment hospital [20] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [21] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
0810 - Darwin
Recruitment postcode(s) [4] 0 0
4032 - Brisbane
Recruitment postcode(s) [5] 0 0
4020 - Redcliffe
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [10] 0 0
5011 - Woodville South
Recruitment postcode(s) [11] 0 0
3350 - Ballarat
Recruitment postcode(s) [12] 0 0
3550 - Bendigo
Recruitment postcode(s) [13] 0 0
3076 - Epping
Recruitment postcode(s) [14] 0 0
3199 - Frankston
Recruitment postcode(s) [15] 0 0
3220 - Geelong
Recruitment postcode(s) [16] 0 0
3084 - Heidelberg
Recruitment postcode(s) [17] 0 0
3004 - Melbourne
Recruitment postcode(s) [18] 0 0
3010 - Melbourne
Recruitment postcode(s) [19] 0 0
3121 - Melbourne
Recruitment postcode(s) [20] 0 0
3128 - Melbourne
Recruitment postcode(s) [21] 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/study/NCT03292237
Trial related presentations / publications
Ridley 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.
Ridley 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.
Ridley 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.
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
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/NCT03292237