None listed
Conditions
Brief summary
When a critically ill patient cannot tolerate feeding delivered into the stomach, a special feeding solution (parenteral nutrition) is commonly given directly into the blood stream (intra-venous) to feed the patient. A recently published review of the literature suggested that lives could be saved if intra-venous feeding was provided earlier (within 24 hours of intensive care unit (ICU) admission) than it is currently provided. Because intra-venous feeding may be more expensive than standard care, we plan to conduct a multi-centre randomised controlled trial comparing the effects of early intra-venous feeding to standard care in patients who require at least two days of care in the intensive therapy unit. The trial will show whether earlier intra-venous feeding improves survival, reduces hospital length of stay and improves other measures of the patient's severity of illness.
Interventions
Patients will be rdx to receive early parenteral nutrition or standard care. Early PN will be initiated within 24 h of ICU admission at a rate to achieve approx 25-30kcals/kg per day. Early PN will be maintained until enteral nutrition (EN) is initiated. In this effectiveness trial, the duration of early PN will be PRN. The duration of standard care will be determined at the discretion of the attending physician (PRN), as long as the patient remains in the ICU.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be screened for eligibility as soon as practical after admission to the study ICU. Patients will be considered eligible for the trial if the following criteria are addressed at the time of screening:Inclusion criteria: The patient is not currently receiving oral, enteral or parenteral nutritional support; The treating physician does not expect to begin oral, enteral or parenteral nutritional support within 24 hours.
Exclusion criteria
The treating physician expects to discharge the patient from the ICU within 24 hours; The patient's ICU length of stay at time of screening is greater than 24 hours; Parenteral nutrition cannot be started within 24 hours of ICU admission; There is an absolute contraindication for enteral nutrition and the patient would normally be supported with parenteral nutrition (Ex. The patient receives chronic home PN); The patient is admitted to the ICU for treatment of thermal injury (burns); The patient is admitted to the ICU for palliative care; The patient is moribund and not expected to survive 24 hours; The patient is brain dead or suspected to be brain dead; The patient was admitted to the study ICU directly from another ICU; The treating physician believes there is an absolute contraindication to treatment received in either study arm.
Outcome results
None listed