A Phase 2 interventional study of Supplemental parenteral nutrition in Critical Illness and Critically Ill, sponsored by Australian and New Zealand Intensive Care Research Centre. Completed at 23 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Australian and New Zealand Intensive Care Research Centre · Phase 2, Interventional, and Supportive care
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.
Background:
Nutrition is a commonly provided therapy in critical illness, but data about effectiveness is sparse. Best practice guidelines recommend enteral nutrition (EN), a specialised solution delivered into the gastrointestinal tract, as the first line of nutrition therapy. The majority of best practice guidelines also recommend delivery of energy and protein amounts close to predicted requirements in critical illness over the course of Intensive Care Unit (ICU) admission, however the only evidence to support this is from observational data. Although recommended that energy and protein requirements be met, and observational data suggests this is of benefit, there are practical challenges with the provision of EN. International practice surveys report the average energy and protein provided is approximately 59% of the patients predicted requirements, for multifactorial reasons. The addition of parenteral (intravenous) nutrition has been proposed as a method to provide additional energy when EN is insufficient, termed supplemental parenteral nutrition (PN). The ability of this strategy to deliver additional energy and protein to patients during critical illness has been proven in several feasibility/pilot trials, but the benefit on clinical and functional outcomes is unknown.
Despite observational data suggesting benefit when energy and protein delivery is optimised close to requirements, no large scale randomised controlled trials (RCTs) have confirmed improved clinical outcomes 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; the interventions may have been applied at a time when the patient's metabolism is not in a phase of recovery; interventions have been short in duration and; studies have not addressed what happens to nutrition intake in the post ICU period of hospitalisation in critically ill individuals.
Aims:
To determine whether the use of a pre-tested supplemental PN strategy in the ICU and an intensive nutrition intervention after discharge to the hospital ward is feasible and will deliver more total energy than standard nutrition care over the entire hospital stay, in critically ill patients with at least one organ system failure.
A further aim is to develop a research program that will determine whether optimisation of energy to critically ill patients over the entire period of hospitalisation improves clinically-meaningful outcomes.
Hypothesis:
In critically ill patients with at least one organ failure, the use of a supplemental PN strategy in ICU and an intensive nutrition intervention on the hospital ward will lead to an increase in daily energy delivery of at least 15% over the entire hospital stay when compared to standard care.
Fifteen percent has been estimated as the minimum acceptable clinical difference between the two groups.
Objectives:
The major objectives are:
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 240 is above the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Australian and New Zealand Intensive Care Research Centre is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients in intensive care who meet all of the following will be eligible:
Have 1 or more organ system failure (respiratory, cardiovascular or renal) related to their acute illness defined as:
Currently on 1 or more continuous inotrope/vasopressor infusion which were started at least 4 hours ago at a minimum dose of:
Renal dysfunction defined as:
Exclusion criteria
Patients will be excluded if:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Dietary Supplement: Supplemental parenteral nutrition
Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
Daily energy delivered from nutrition therapy
Daily energy delivered from nutrition therapy
Time frame: Day 28
Nutrition intake
Daily protein intake, Energy and protein intake by location (ICU and ward)
Time frame: Day 28
Duration hospital stay
Duration of hospital stay in survivors and non-survivors
Time frame: Day 28
Ventilator Free Days
Ventilator Free Days (VFDs) at study day 28
Time frame: Day 28
Total blood stream infection rate
Total blood stream infection rate
Time frame: Day 28
Duration of ICU stay
Duration of ICU stay in survivors and non survivors
Time frame: Day 28
Duration of Mechanical Ventilation
Duration of Mechanical Ventilation to study day 28 in survivors and non-survivors
Time frame: Day 28
ICU mobility scale
ICU mobility scale at ICU discharge
Time frame: Day 28
Mortality
In hospital and 28 day mortality
Time frame: Day 28
Blood stream infections
Number of blood stream infections to day 28, time to any blood stream infection
Time frame: Day 28
Weight
Weight at hospital discharge
Time frame: Day 28
Frailty
Clinical frailty score
Time frame: 90 days
European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L)
Health related quality of life assessment using EQ5D-5L. Each dimension has 5 levels ranging from no problems (1) to extreme problems (5), there is no overall score. It also has a visual analogue scale (VAS) ranging 0-100 with 0 being worst imaginable health state and 100 being best imaginable health state
Time frame: 90 days
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
WHODAS is a 12 point disability assessment with a raw score range of 0-48. 0 is no disability and 48 being full disability
Time frame: 90 days
European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L)
Health related quality of life assessment using EQ5D-5L. Each dimension has 5 levels ranging from no problems (1) to extreme problems (5), there is no overall score. It also has a visual analogue scale (VAS) ranging 0-100 with 0 being worst imaginable health state and 100 being best imaginable health state
Time frame: 180 days
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
WHODAS is a 12 point disability assessment with a raw score range of 0-48. 0 is no disability and 48 being full disability
Time frame: 180 days
Cost per quality adjusted life year
Cost per quality adjusted life year (QALY)
Time frame: 180 days
Cost per life year gained
Cost per life year gained (LYG)
Time frame: 180 days
Frailty
Clinical frailty score
Time frame: 180 dyas
Plan to share: Yes — Data sharing requests will be considered 2 years after publication of the primary trial data on an individual basis by the trial management committee (the data custodians). Data sharing will only be considered for investigator-initiated, independent researchers who provide a written data evaluation proposal that is judged to be methodologically sound. A data sharing agreement will be required to detail conditions under which data is shared and used. Resulting publications should appropriately cite and acknowledge the original data custodians. Requests for data sharing are to be made to anzicrc@monash.edu and the corresponding author, Dr Emma Ridley; emma.ridley@monash.edu
Ran from Oct 2018 to primary completion in Feb 2023, 52 months.
Of 36 phase 2 interventional studies under Critical Illness, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 39. This study's 52 months is above that.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Australian and New Zealand Intensive Care Research Centre