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Intensive Nutrition in Critically Ill Adults (INTENT)

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ClinicalTrials.gov Identifier: NCT03292237
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Australian and New Zealand Intensive Care Research Centre

Study Description
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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.


Condition or disease Intervention/treatment Phase
Critical Illness Critically Ill Dietary Supplement: Supplemental parenteral nutrition Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicentre, prospective, parallel, randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.

 Dietary Supplement: Supplemental parenteral nutrition
Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)


Outcome Measures
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Primary Outcome Measures :
  1. Daily energy delivered from nutrition therapy [ Time Frame: Day 28 ]
    Daily energy delivered from nutrition therapy


Secondary Outcome Measures :
  1. Nutrition intake [ Time Frame: Day 28 ]
    Daily protein intake, Energy and protein intake by location (ICU and ward)

  2. Duration hospital stay [ Time Frame: Day 28 ]
    Duration of hospital stay in survivors and non-survivors

  3. Ventilator Free Days [ Time Frame: Day 28 ]
    Ventilator Free Days (VFDs) at study day 28

  4. Total blood stream infection rate [ Time Frame: Day 28 ]
    Total blood stream infection rate


Other Outcome Measures:
  1. Duration of ICU stay [ Time Frame: Day 28 ]
    Duration of ICU stay in survivors and non survivors

  2. Duration of Mechanical Ventilation [ Time Frame: Day 28 ]
    Duration of Mechanical Ventilation to study day 28 in survivors and non-survivors

  3. ICU mobility scale [ Time Frame: Day 28 ]
    ICU mobility scale at ICU discharge

  4. Mortality [ Time Frame: Day 28 ]
    In hospital and 28 day mortality

  5. Blood stream infections [ Time Frame: Day 28 ]
    Number of blood stream infections to day 28, time to any blood stream infection

  6. Weight [ Time Frame: Day 28 ]
    Weight at hospital discharge

  7. Frailty [ Time Frame: 90 days ]
    Clinical frailty score

  8. European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L) [ Time Frame: 90 days ]
    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

  9. World Health Organization Disability Assessment Schedule 2.0 (WHODAS) [ Time Frame: 90 days ]
    WHODAS is a 12 point disability assessment with a raw score range of 0-48. 0 is no disability and 48 being full disability

  10. European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L) [ Time Frame: 180 days ]
    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

  11. World Health Organization Disability Assessment Schedule 2.0 (WHODAS) [ Time Frame: 180 days ]
    WHODAS is a 12 point disability assessment with a raw score range of 0-48. 0 is no disability and 48 being full disability

  12. Cost per quality adjusted life year [ Time Frame: 180 days ]
    Cost per quality adjusted life year (QALY)

  13. Cost per life year gained [ Time Frame: 180 days ]
    Cost per life year gained (LYG)

  14. Frailty [ Time Frame: 180 dyas ]
    Clinical frailty score


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292237


Contacts
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Contact: Emma Ridley, PhD +614399030350 emma.ridley@monash.edu
Contact: Eliza Miller, PhD +614399030217 Eliza.Miller@monash.edu

Locations
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Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Emma Ridley, PhD ANZIC-RC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT03292237    
Other Study ID Numbers: ANZIC-RC/ER001
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Australian and New Zealand Intensive Care Research Centre:
Energy
Nutrition
Critical illness
Parenteral nutrition
 Intensive care unit
Ward
Randomised Controlled Trial
Intensive Nutrition
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes