Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000830796
Ethics application status
Approved
Date submitted
29/05/2013
Date registered
29/07/2013
Date last updated
10/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of the factors affecting outcome for oncology patients admitted to the Intensive Care Unit (ICU) during the course of their treatment at Launceston General Hospital, Tasmania.
Scientific title
Analysis of the factors affecting outcome for oncology patients admitted to ICU during the course of their treatment at Launceston General Hospital, Tasmania.
Secondary ID [1] 282596 0
Nil
Universal Trial Number (UTN)
Trial acronym
ICU ONCOLOGY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oncological Malignancies 289291 0
Haematological Malignancies 289292 0
Condition category
Condition code
Cancer 289611 289611 0 0
Any cancer
Public Health 289622 289622 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will investigate all patients with cancer who were admitted to the Intensive Care Unit at the Launceston General Hospital between 2006 and 2012. The data from this trial will help to assess factors that may determine the survival of oncology patients who require an admission to the ICU during the course of their treatment.
To document treatment modalities or any other related data for these patients in correlation to outcome.
To record any complications secondary to the admission to the ICU for future references.
Intervention code [1] 287267 0
Not applicable
Comparator / control treatment
No Comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289703 0
Assess patient outcome of Oncology ICU patients
Assessed by resolution of the cause of admission to ICU, or persistance of damage (i.e. organ failure) or adverse outcome with death.
Timepoint [1] 289703 0
01/01/2006 - 31/12/2012
Secondary outcome [1] 303053 0
Effect of different types of organ failure on outcome
This will be assessed by measuring all organ functions.
Timepoint [1] 303053 0
01/01/2006 - 31/12/2012
Secondary outcome [2] 303064 0
Effect of period of neutropenia on outcome
This will be assessed by measuring FBC.
Timepoint [2] 303064 0
Jan 2006 to Dec 2012
Secondary outcome [3] 303065 0
Type of underlying malignancy or treatment in relation to outcome
This will be assessed by correlating the underlying cancer diagnosis and treatment with the outcome.
Timepoint [3] 303065 0
Jan 2006 till Dec 2012
Secondary outcome [4] 303066 0
Presence of sepsis or atypical infection on outcome
This will be assessed by correlating the recorded type of sepsis or infection with the outcome.
Timepoint [4] 303066 0
Jan 2006 till Dec 2012
Secondary outcome [5] 303067 0
Effect of presence of sepsis or atypical infection on outcome
This will be assessed by correlating the recorded type of sepsis or infection with the outcome.
Timepoint [5] 303067 0
Jan 2006 -Dec 2012
Secondary outcome [6] 303068 0
Effect of APACHE Score related to patient outcome
This will be assessed by correlating the recorded APACHE scores with the outcome.
Timepoint [6] 303068 0
Jan 2006-Dec 2012
Secondary outcome [7] 303069 0
Effect of readmission to ICU on outcome
This will be assessed by correlating the rate of readmission on patients overall outcome.
Timepoint [7] 303069 0
Jan 2006- Dec 2012

Eligibility
Key inclusion criteria
Any oncology patient who has been admitted to ICU at the Launceston General Hospital, Tasmania (LGH) during the course of their treatment or diagnosis of their cancer
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
All statistical analysis will be descriptive and exploratory in nature. For categorical data, frequency tables will be produced including two-sided 95% confidence intervals for
proportions where applicable. For continuous data, descriptive statistics will be calculated and two sided 95% confidence intervals for means will be provided where appropriate. Exploratory analyses might use for example, logistic regression, analysis of covariance or Cox proportional hazards regression method.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2013
Actual
10/01/2013
Date of last participant enrolment
Anticipated
31/12/2013
Actual
31/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
730
Accrual to date
Final
537
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 1069 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 6929 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 287376 0
Charities/Societies/Foundations
Name [1] 287376 0
Clifford Craig Medical Trust Fund
Country [1] 287376 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Charles street
Launceston, Tasmania, 7250 Australia
Country
Australia
Secondary sponsor category [1] 286122 0
None
Name [1] 286122 0
None
Address [1] 286122 0
Country [1] 286122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289351 0
Tasmanian Human Ethics Committee
Ethics committee address [1] 289351 0
University of Tasmania
Private Bag 01
Hobart, Tas 7001
Ethics committee country [1] 289351 0
Australia
Date submitted for ethics approval [1] 289351 0
Approval date [1] 289351 0
02/01/2013
Ethics approval number [1] 289351 0
H0012919

Summary
Brief summary
Oncology and Haematology patients are at increased risk to be admitted to the ICU during the course of their treatment, especially when they present with an advanced or aggressive disease. Unfortunately there is high mortality rate among this cohort of patients. There are many factors that may play a crucial role such as presence of organ failure, intubation status, oxygen saturation and compromise to the cardiovascular system. It is important to study all these factors as well as other factors such as underlying disease and disease status in order to predict patient outcome. There are paucity of data in this regard and therefore it highlights the importance of this audit in our hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40438 0
Prof Alhossain Khalafallah
Address 40438 0
Launceston General Hospital, Charles Street, Launceston TAS 7250
Country 40438 0
Australia
Phone 40438 0
+61373487111
Fax 40438 0
+61373487695
Email 40438 0
[email protected]
Contact person for public queries
Name 40439 0
Prof Alhossain Khalafallah
Address 40439 0
Launceston General Hospital, Charles Street, Launceston TAS 7250
Country 40439 0
Australia
Phone 40439 0
+61373487111
Fax 40439 0
+61373487695
Email 40439 0
[email protected]
Contact person for scientific queries
Name 40440 0
Prof Alhossain Khalafallah
Address 40440 0
Launceston General Hospital, Charles Street, Launceston TAS 7250
Country 40440 0
Australia
Phone 40440 0
+61373487111
Fax 40440 0
+61373487695
Email 40440 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.