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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 082059
ACTR Number: ACTRN12608000407392
Trial Status: Registered
Date Submitted: 31/05/2007
Date Registered: 19/08/2008

Page 1

Public title: Australian and New Zealand Cluster Randomised trial of Evidence-based Guidelines for Nutrition Support in Critical Illness
ANZCTR registration title: Cluster randomised trial evaluating the impact on mortality of evidence based guidelines for nutritional support in critical illness
Secondary ID: 
UTN:
Trial acronym:

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Health condition(s) or problem(s) studied:
Critical illness, fasting, starvation, malnourishment 
Condition category: Condition code:
Diet and nutrition Other diet and nutrition disorders 

Page 3

Description of intervention(s) / exposure: The study intervention involves the implementation of National-level guidelines for the provision of nutritional support in critical illness. 27 hospitals participated in this trial: 14 hospitals were randomised to the intervention group (guidelines implementation) and 13 were randomised to the control (standard care) group. The 14 intervention group hospitals received education on the content of the feeding guidelines and the 13 control hospitals received no education. Education was provided via a formal practice change strategy composed of Educational Outreach (one session, 45-60mins), Academic Detailing (as much as required), Posters, Active Reminders, Audit and Feedback and traditional in-servicing (as many sessions as required, 30-60mins per session).
Intervention code 1:Prevention 
Intervention code 2:Other interventions 
Comparator / control treatment: In the Control / Standard Care arm of the trial, hospitals received no educational intervention and continued to practice nutritional support as determined by current local standards.
Control group: Active

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Primary outcome 1:Mortality 
Timepoint:Hospital Discharge 
Primary outcome 2:Mortality 
Timepoint:Hospital Discharge 
Primary outcome 3:Mortality 
Timepoint:Hospital Discharge 
Secondary outcome 1:organ dysfunction, resource consumption, severity of illness 
Timepoint:during ICU stay 
Secondary outcome 2:Severity of illness / measures of morbidity 
Timepoint:Durint ICU stay 
Secondary outcome 3:morbidity 
Timepoint:during ICU stay 

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Key inclusion criteria: Adult patients expected to require ICU care for longer than 2 days.
Minimum Age: 18 Years
Maximum Age: Not stated
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: 1. Already tolerating an adequate oral diet; 2. Scheduled to return to oral intake within 24 hours; 3. Admitted to ICU for palliative care; 4. Moribund and not expected to survive 6 hours; 5. Brain dead or suspected to be brain dead; 6. Admitted directly to the study ICU from any other ICU.

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Study type: Interventional
Purpose of the study: Prevention
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): This was a cluster randomised trial. Hospitals (not patients) were randomised to implement the guideline or remain as controls. After agreeing to participate in the study, hospitals were randomised using a centralised computer program developed in SAS.
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Permuted block randomisation, stratifed by key hospital characteristics (bed number), generated using SAS.
Masking / blinding: Open (masking not used)
Assignment: Parallel
Other design features (specify): Cluster randomised. Hospitals (not patients) were randomised to receive and implement and evidence-based guideline or to remain as control (no guideline) hospitals.
Type of endpoint(s): Efficacy

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Phase Phase 3 / Phase 4
Anticipated or actual start date: 1/04/2003
Target sample size: 1500
Recruitment status: Completed

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Funding source:Charities/Societies/Foundations 
Name:ANZIC Foundation 
Address:Level 2, 10 Ievers Terrace - CARLTON VIC 3053 
Country:Australia 
Primary sponsor: Individual
Name: Dr Gordon Doig
Address: Northern Clinical School University of Sydney Sydney 2006
Country: Australia
Secondary sponsor:None 
Name: 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:University of Sydney 
Address:University of Sydney Human Research Ethics Committee, Sydney, NSW 2006 
Country:Australia 
Date of approval:26/06/2003 
HREC Number:0209-150M 
Countries of recruitment:Australia 
Brief summary: Nutritional support is accepted as a standard of care for critically ill patients although there is little agreement as to how it is best provided. Use of evidence-based guidelines has been shown to improve the effectiveness of care. The purpose of this project is to develop, promote and evaluate evidence-based clinical practice guidelines for nutritional support in the ICU in twenty-six hospitals throughout Australia and New Zealand. One half of the hospitals will be randomised to receive educational sessions based on the content of the guidelines using previously proven and accepted educational strategies. A cluster randomised trial will then evaluate the impact of these educational sessions on acceptance of the guideline and on patient outcomes.
Trial website:
Presentations / publication list:

Page 10

Contact person for public queries
Name: Dr Gordon Doig
Address: Intensive Care Unit (ICU)
Royal North Shore Hospital (RNSH)
Pacific Highway
St Leondards NSW 2065
Country: Australia
Tel: +61 2 99268656
Fax: +61 2 94398418
Email: gdoig@med.usyd.edu.au

Contact person for scientific queries
Name: Dr Gordon Doig
Address: Intensive Care Unit (ICU)
Royal North Shore Hospital (RNSH)
Pacific Highway
St Leondards NSW 2065
Country: Australia
Tel: +61 2 99268656
Fax: +61 2 94398418
Email: gdoig@med.usyd.edu.au

Contact person responsible for updating information
Name: Dr Gordon Doig
Address: Intensive Care Unit (ICU)
Royal North Shore Hospital (RNSH)
Pacific Highway
Country: Australia
Tel: 612 9926 8656
Fax: 612 9439 8418
Email: gdoig@med.usyd.edu.au
   
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