Intensive Nutrition in Critically Ill Adults

NCT03292237 | Completed Phase 2

• 1 other identifier: ANZIC-RC/ER001
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 23

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.

Conditions

Critical Illness; Critically Ill

Keywords

Energy; Nutrition; Critical illness; Parenteral nutrition; Intensive care unit; Ward; Randomised Controlled Trial; Intensive Nutrition

Outcome Measures

Primary Outcomes (1)

• Daily energy delivered from nutrition therapy

  Daily energy delivered from nutrition therapy

  Day 28

Secondary Outcomes (4)

• Nutrition intake

  Day 28

• Duration hospital stay

  Day 28

• Ventilator Free Days

  Day 28

• Total blood stream infection rate

  Day 28

Other Outcomes (14)

• Duration of ICU stay

  Day 28

• Duration of Mechanical Ventilation

  Day 28

• ICU mobility scale

  Day 28

Study Arms (2)

Standard Nutrition Arm

NO INTERVENTION

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.

Intensive Arm

EXPERIMENTAL

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

Interventions

Supplemental parenteral nutrition DIETARY_SUPPLEMENT

Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)

Intensive Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in intensive care who meet all of the following will be eligible:
• Admitted to intensive care between 72 hours and 120 hours
• Receiving invasive ventilator support
• At least 18 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:
• 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:
• Noradrenaline ≥ 0.1mcg/kg/min
• Adrenaline ≥ 0.1 mcg/kg/min
• Any dose of vasopressin
• Milrinone \> 0.1 mcg/kg/min
• Renal dysfunction defined as:
• Serum creatinine 2.0-2.9 times baseline OR
• Urine output 0.5ml/kg/hr for ≥ 12 hours OR

You may not qualify if:

• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (23)

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

Royal Darwin Hospital

Darwin, Northern Territory, 0810, Australia

Location

Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

Redcliffe Hospital

Redcliffe, Queensland, 4020, Australia

Location

Mater Hospital

South Brisbane, Queensland, 4101, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Lyell McEwin

Elizabeth Vale, South Australia, 5112, Australia

Location

Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia

Location

Ballarat Hospital

Ballarat, Victoria, 3350, Australia

Location

Bendigo Hospital

Bendigo, Victoria, 3550, Australia

Location

Northern Hospital

Epping, Victoria, 3076, Australia

Location

Frankston Hospital - Peninsula Health

Frankston, Victoria, 3199, Australia

Location

Geelong Hospital

Geelong, Victoria, 3220, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3010, Australia

Location

Epworth Richmond

Melbourne, Victoria, 3121, Australia

Location

Box Hill Hospital

Melbourne, Victoria, 3128, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

Auckland City Hospital CVICU

Auckland, 1023, New Zealand

Location

Middlemore Hospital

Auckland, 2025, New Zealand

Location

Related Publications (4)

• Ridley EJ, Bailey M, Chapman MJ, Chapple LS, Deane AM, Gojanovic M, Higgins AM, Hodgson CL, King VL, Marshall AP, Miller EG, McGuinness SP, Parke RL, Paul E, Udy AA; Australian, New Zealand Intensive Care Society Clinical Trials Group. The impact of a tailored nutrition intervention delivered for the duration of hospitalisation on daily energy delivery for patients with critical illness (INTENT): a phase II randomised controlled trial. Crit Care. 2025 Jan 6;29(1):8. doi: 10.1186/s13054-024-05189-3.

  PMID: 39762887 DERIVED

• 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.

  PMID: 35260448 DERIVED

• 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.

  PMID: 33315720 DERIVED

• 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.

  PMID: 29924393 DERIVED

MeSH Terms

Conditions

Critical Illness; Hyperphagia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Emma Ridley, PhD

  ANZIC-RC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicentre, prospective, parallel, randomised controlled trial

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 25, 2017
• Study Start: October 15, 2018
• Primary Completion: February 27, 2023
• Study Completion: July 31, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

NZ (2); AU (21)