CompletedPhase 3ACTRN12605000704695

Early PN trial

The effects of early parenteral nutrition compared to standard care on 60 day landmark mortality in the critically ill patient: A level I randomised controlled trial.


Sponsor

University of Sydney

Enrollment

1,470 participants

Start Date

Sep 21, 2006

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study tests whether starting parenteral nutrition (feeding through an IV) early in an ICU stay improves outcomes for critically ill patients. Both men and women who are admitted to an ICU and not currently receiving any nutritional support may be eligible. Participants would be randomly assigned to receive either early IV nutrition or standard care.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Australia

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ACTRN12605000704695