Status:
COMPLETED
Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
Lead Sponsor:
Australian and New Zealand Intensive Care Research Centre
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Multiple Organ Failure
Critical Illness
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
One of the essential treatments for assisting patients in their recovery from illness is the provision of nutrition in a liquid form which is delivered into the stomach or as a fluid into the vein. Un...
Detailed Description
The principal objectives are: 1. To determine whether the supplemental Parenteral Nutrition (PN) strategy leads to the delivery of increased amounts of total nutrition (measured as energy delivered),...
Eligibility Criteria
Inclusion
- Patients in intensive care who meet all of the following:
- Admitted to intensive care between 48 hours and 72 hours previously
- Mechanically ventilated at the time of enrollment and expected to remain ventilated until the day after tomorrow
- At least 16 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:
- Partial pressure of oxygen (PaO2) / Fraction of Inspired oxygen (FiO2) ratio ≤ 300 mmHg
- Currently on 1 or more continuous vasopressor infusion which were started at least 4 hours ago at a minimum dose of :
- Dopamine greater than 5 mcg/kg/min
- Noradrenaline ≥ 0.1mcg/kg/min
- Adrenaline ≥ 0.1 mcg/kg/min
- Any dose of total vasopressin
- Milrinone \>0.25mcg/kg/min)
- Renal dysfunction defined as
- In patients without known renal disease:
- serum creatinine \> 171 mmol/l OR
- Currently receiving renal replacement therapy
- In patients with known renal disease:
- an absolute increase of \> 50% in creatinine from baseline OR
- Currently receiving renal replacement therapy
- Currently has an intracranial pressure monitor or ventricular drain in situ
- Currently receiving extracorporeal membrane oxygenation
- Currently has a ventricular assist device
Exclusion
- Both EN and PN cannot be delivered at enrollment (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
- Standard PN solutions cannot be delivered at enrolment (i.e. clinicians believe that a patient definitely needs a specific parenteral nutrition formulation (e.g. glutamine-supplementation or specific lipid formulation).
- Death is imminent or deemed highly likely 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 illness
- More than 80% of energy requirements have been satisfactorily delivered via the enteral route in the last 24 hours.
- Are known to be pregnant
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01847534
Start Date
February 1 2014
End Date
July 1 2016
Last Update
August 2 2016
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
2
Geelong Hospital
Geelong, Australia
3
Auckland City Hospital (CVICU)
Auckland, New Zealand
4
Auckland City Hospital (DCCM)
Auckland, New Zealand