Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001218987
Ethics application status
Not yet submitted
Date submitted
23/11/2011
Date registered
28/11/2011
Date last updated
28/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Early temperature and mortality in critically ill patients with neurological injury.
Scientific title
The association between early temperature and mortality in critically ill patients with neurological injury admitted to an adult ICU.
Secondary ID [1] 273450 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischamic and Haemorrhagic Stroke, including Subarachnoid Haemorrhage + Traumatic Brain Injury 279242 0
Central Nervous System Infection 279243 0
Condition category
Condition code
Neurological 279444 279444 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective cohort study: The exposure is peak temperature in the first 24 hours of intensive care admission and this will be treated as a categorical variable, divided into 0.5 degrees celsius increments. We will report odds ratios for risk of death relative to normal temperature defined as the range from 36.0 degrees to 37.5 degrees celcius.

The outcome reported in the retrospective database is mortality at hospital discharge.

The study will include all patients admitted to an adult ICU at one of 129 centres in Australia and New Zealand (ANZ) or one of 201 centres in the United Kingdom (UK) between 2005 and 2010.
Intervention code [1] 283775 0
Not applicable
Comparator / control treatment
All patients admitted to an adult ICU at one of 129 centres in Australia and New Zealand (ANZ) or one of 201 centres in the United Kingdom (UK) between 2005 and 2010 with an admission diagnostic code of central nervous sytem infection.
Control group
Historical

Outcomes
Primary outcome [1] 286011 0
Unadjusted hospital mortality. This information will be obtained from medical records.
Timepoint [1] 286011 0
Hospital discharge
Secondary outcome [1] 294970 0
Discharge destination (discharge home vs. death and any other discharge destination). This information will be obtained from medical records.
Timepoint [1] 294970 0
Hospital Discharge

Eligibility
Key inclusion criteria
We will include patients with a diagnosis of traumatic brain injury, ischaemic stroke, subarachnoid haemorrhage, intracranial haemorrhage and central nervous system infections according to the coding systems of the ANZICS APD (APACHE III Diagnostic Categories) and the ICNARC Coding Method (ICM).


ANZICS APD Codes: 1601, 601, 409, 1502, 403, 402, 1503, 1501, 401, 404

ICNARC Codes:1.4.2.38.1 to 1.4.2.38.8, 2.4.2.38.1 to 2.4.2.38.8, 1.4.2.15.2, 1.4.2.41.1, 1.4.2.41.2, 2.4.2.15.2, 2.4.2.41.1, 2.4.2.41.2, 2.4.2.41.3, 1.4.2.15.1, 1.4.2.15.3 to 1.4.2.15.4, 2.4.2.15.1, 2.4.2.15.3 to 2.4.2.15.41.4.2.27.1 to 1.4.2.27.3, 1.4.2.27.5 to 1.4.2.27.8, 2.4.2.27.1 to 2.4.2.27.3, 2.4.2.27.5 to 2.4.2.27.8
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients admitted following a cardiac arrest due to the confounding effect of therapeutic hypothermia; patients with missing data for either temperature, or admission diagnosis or vital status at hospital discharge; and patients with insufficient information on GCS. Where patients are admitted to ICU more than once during a hospital admission, only the patient’s first admission will be included in the analysis.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3974 0
New Zealand
State/province [1] 3974 0
Country [2] 3975 0
United Kingdom
State/province [2] 3975 0

Funding & Sponsors
Funding source category [1] 284254 0
University
Name [1] 284254 0
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC) and the Intensive Care National Audit & Research Centre (ICNARC)
Country [1] 284254 0
Australia
Primary sponsor type
University
Name
Australian and New Zealand Intensive Care Society Centre for Outcomes and Resource Evaluation
Address
10 Ievers Terrace, Carlton South, VIC AUSTRALIA 3053
Fax: +61 3 9340 3499
Country
Australia
Secondary sponsor category [1] 269207 0
University
Name [1] 269207 0
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)
Address [1] 269207 0
ANZIC-RC
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country [1] 269207 0
Australia
Secondary sponsor category [2] 269208 0
University
Name [2] 269208 0
Intensive Care National Audit and Research Centre (ICNARC)
Address [2] 269208 0
Entrance A
Tavistock House
Tavistock Square
London
WC1H 9HR
Country [2] 269208 0
United Kingdom

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286218 0
Ethics committee address [1] 286218 0
Ethics committee country [1] 286218 0
Date submitted for ethics approval [1] 286218 0
01/01/2012
Approval date [1] 286218 0
Ethics approval number [1] 286218 0

Summary
Brief summary
Fever is common in critically ill patients. Maintaining a normal temperature (“normothermia”) in the acute phase after brain injury is considered to be the default clinical practice. This is based on theoretical rationale, data from animal studies, and, observational clinical studies. In the context of neurological injury, the febrile response may be a marker of illness severity, may potentially represent a modifiable risk factor for morbidity and mortality, or, may be linked to a protective host response to illness.

We intend to test the hypothesis that early fever would have an independent association with worse outcome in the presence of neurological injury except for neurological infection. Specifically, we hypothesize that peak temperature during the first 24 hours after ICU admission would be associated with increased mortality in patients admitted with an admission diagnostic codes for stroke and TBI, but, reduced mortality, in those with neurological infections.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33431 0
Address 33431 0
Country 33431 0
Phone 33431 0
Fax 33431 0
Email 33431 0
Contact person for public queries
Name 16678 0
Manoj Saxena
Address 16678 0
The George Institute for Global Health
Level 7, 341 George Street
Sydney NSW 2000
AUSTRALIA
Telephone
Facsimile +61 2 9657 0301
Country 16678 0
Australia
Phone 16678 0
+61 2 9657 0381
Fax 16678 0
+61 2 9657 0301
Email 16678 0
[email protected]
Contact person for scientific queries
Name 7606 0
Manoj Saxena
Address 7606 0
The George Institute for Global Health
Level 7, 341 George Street
Sydney NSW 2000
AUSTRALIA
Country 7606 0
Australia
Phone 7606 0
+61 2 9657 0381
Fax 7606 0
+61 2 9657 0301
Email 7606 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.