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The Augmented Versus Routine Approach to Giving Energy Trial

NCT02306746 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2018-09-13

No results posted yet for this study

Summary

Nutrition therapy is an essential standard of care for all critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days.

The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial to determine if augmentation of calorie delivery using energy dense enteral nutrition in mechanically ventilated patients improves 90 day survival when compared to routine care.

Conditions

  • Critical Illness

Interventions

DIETARY_SUPPLEMENT

TARGET protocol EN 1.5 kcal/mL

Enteral feed 1.5 kcal/mL

DIETARY_SUPPLEMENT

TARGET protocol EN 1.0 kcal/mL

Enteral feed 1.0 kcal/mL

Sponsors & Collaborators

  • Australian and New Zealand Intensive Care Research Centre

    lead OTHER

Principal Investigators

  • Sandra Peake, MD · University of Adelaide

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-16
Primary Completion
2018-07-10
Completion
2018-08-01

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02306746 on ClinicalTrials.gov