The TARGET Study

The importance of nutrition in critical illness is widely recognised, yet there remains uncertainty about the optimal target for caloric requirements. The TARGET trial is a pivotal, 4000-patient, multi-centre, double-blinded, randomised, controlled, parallel-group, phase III clinical trial. It’s aim is to determine if the delivery of more calories improves survival in critically ill patients who are mechanically ventilated and remain in intensive care for more than a few days.

The TARGET Study

Background

  • Nutrition therapy is an essential standard of care for all ICU patients who are mechanically ventilated and remain in ICU for more than a few days
  • Enteral nutrition (via a nasogastric tube) is usually initiated within 24 hours of ICU admission
  • Previous trials support the concept that optimising nutrition in the critically ill will improve outcome, however, the evidence is limited, inconclusive and generally of low quality

Facts

  • Each year around 130,000 Australians are admitted to ICU at a daily cost of approximately $4000 per patient
  • Critically ill patients require substantial resources and multiple interventions, some die and many of those who survive have delayed and compromised functional recovery which can persist for months or years

Aims

Primary: 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.

Secondary: to determine if augmentation of calorie delivery using energy dense enteral nutrition in mechanically ventilated patients improves functional outcomes when compared to routine care.

Methods

  • A 4000 patient, multi-centre, double-blinded, randomised, controlled, parallel-group, phase III clinical trial.
  • Eligible patients will be randomised 1:1 to receive TARGET protocol enteral nutrition formulation of either 1 kcal/ml or 1.5 kcal/ml
  • TARGET will be conducted in ICUs in Australia and New Zealand

About Spinnaker and The TARGET Trial

Friendly interface streamlines data collection

As Monash University had not used an online inventory management system before they looked to previous trials with other institutions, for recommendations. Lorraine Little, Senior Project Manager for TARGET says,

“We had not used Spiral before but we knew that they had done the SuppPN trial which was a very useful reference for us. When we talked to their Project Manager about Spirals’ Spinnaker software, they said it was really easy to use,the website had an intuitive user interface and was completely reliable”.

Lorraine also knew that Spiral’s software had been used successfully on the HEAT Trial and the Split Trial. She says,

“In our industry word of mouth is very important and getting positive feedback about Spiral from both sides of the Tasman was really encouraging. The TARGET trial is a big trial with many people using the database. It required very intuitive, logical solutions and simple, clear instructions. Nutrition data is also particularly difficult with the challenge of getting the definition completely correct.”

Inventory management made easy with an online solution

With over 100,000 bags of study treatment in this double-blind trial, some smart stock management was needed. All study treatment bags look the same and patient allocation is purely by bag number. Trying to manage such a large database manually is just not feasible. Lorraine Little says,

“Inventory was our biggest concern but with Spinnaker this is managed very easily”,

Primary: 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.

Secondary: to determine if augmentation of calorie delivery using energy dense enteral nutrition in mechanically ventilated patients improves functional outcomes when compared to routine care.

Genuine support coupled with innovative software development

The Spinnaker product has a strong reputation as a very robust, adaptable study management software and when asked about using Spinnaker for the TARGET study Lorraine said,

“Although their technical expertise has proven to be excellent, it is their customer service and problem-solving skills that came to fore as soon as we got underway. We can tell them what we want but we are not programmers so we have no idea how to achieve it. We also don’t know what is possible. Audrey and Cain are excellent at listening to us and coming back with very good solutions. Even when we changed the data sets there was no fuss and it was, “yes we can do that and this is how we will manage it”. And when you see what they come up with you think “oh I wish I had thought of that!””

Supported by:  National Health and medical Research Council (NHMRC), Australia & Fresenius Kabi Deutschland GmbH

Coordinating centre: The ANZIC-RC, School of Public Health and Preventative Medicine, Monash University

Chief Investigator: Professor Marianne Chapman, Director of Research / Senior Staff Specialist Intensive Care Unit, Royal Adelaide Hospital

Contact: Lorraine Little, Senior Project Manager,ANZIC-RC, School of Public Health and Preventative Medicine, Monash University

Software: Spinnaker, Spiral Software

TARGET Case Study – Inventory made easy

TARGET Case Study

Download the TARGET Case Study

TARGET Fact Sheet

TARGET Fact Sheet

Download the TARGET Fact Sheet

Interview with the TARGET Chief Investigator on the Essential Critical Care Podcast

Twitter

Read what people are saying about the TARGET Trial on Twitter

#TARGETtrial

Read what people are saying about the TARGET Trial on Twitter.
#TARGETtrial

Study Database

Sign in to the study (username + password needed)

Study Database

The TARGET Trial is open and enrolling patients. If you have a username and password you can sign in from here.
Study Database

ANZCTR

View this trial on the Australian and New Zealand Clinical Trial Registry

ANZCTR

View this trial on the Australian and New Zealand Clinical Trial Registry. 
ACTRN12611000793910