Australian New Zealand Clinical Trials Registry

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

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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

Diet and nutrition	Other diet and nutrition disorders
Condition category:	Condition code:

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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?

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 date of first participant enrolement:

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:

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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

Trial Details

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