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Status:

COMPLETED

Intensive Nutrition in Critically Ill Adults

Lead Sponsor:

Australian and New Zealand Intensive Care Research Centre

Collaborating Sponsors:

Baxter Healthcare Corporation

Conditions:

Critical Illness

Critically Ill

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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, wi...

Detailed Description

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 del...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • 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
  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 15 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 31 2023

    Estimated Enrollment :

    240 Patients enrolled

    Trial Details

    Trial ID

    NCT03292237

    Start Date

    October 15 2018

    End Date

    July 31 2023

    Last Update

    May 24 2024

    Active Locations (23)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (23 locations)

    1

    Blacktown Hospital

    Blacktown, New South Wales, Australia, 2148

    2

    Nepean Hospital

    Kingswood, New South Wales, Australia, 2747

    3

    Royal Darwin Hospital

    Darwin, Northern Territory, Australia, 0810

    4

    Prince Charles Hospital

    Brisbane, Queensland, Australia, 4032