Early PN trial

Phase 3

Completed

• Conditions: Critical Illness (ICU pts); Diet and Nutrition - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12605000704695
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1470

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: 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
60 day all cause landmark mortality[Day 60]

Secondary Outcome Measures

Name	Time	Method
ICU and hospital length of stay[Measured at ICU and hospital discharge];SF1[Measured at day 60];Degree and days of organ dysfunction[Measured during ICU stay];Days of mechanical ventilation[Measured during ICU stay];Days of renal replacement therapy[Measured during ICU stay];Days of inotrope requirement[Measured during ICU stay];Daily blood glucose levels[Measured during ICU stay];Daily insulin dose[Measured during ICU stay];Duration and severity of pressure ulcers[Measured during ICU stay];Antibiotic usage[Measured during ICU stay];Measures of nutritional status[Measured during ICU stay]