Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000451202
Ethics application status
Approved
Date submitted
21/02/2018
Date registered
28/03/2018
Date last updated
28/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Predictors of clinical outcomes in patients admitted with influenza and whether troponin levels during hospital admission predicts clinical outcomes in patients with influenza?
Scientific title
Predictors of clinical outcomes in patients admitted with influenza and whether troponin levels during hospital admission predicts clinical outcomes in patients with influenza?
Secondary ID [1] 293716 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Influenza 306725 0
myocarditis 306726 0
myocardial infarction 306727 0
pneumonia 306728 0
Condition category
Condition code
Respiratory 305826 305826 0 0
Other respiratory disorders / diseases
Infection 305827 305827 0 0
Other infectious diseases
Cardiovascular 305828 305828 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will determine the factors which are associated with adverse clinical outcomes in patients who are hospitalised due to seasonal influenza and will study association of troponin levels with clinical outcomes in patients with influenza. The troponin levels done at any time during the index admission will be assessed. The clinical outcomes observed will include length of hospital stay (LOS),in-hospital mortality, complications during index admission and number of readmissions within one and six months of hospital discharge.
Intervention code [1] 300403 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304885 0
in-hospital mortality assessed by review of hospital records.
Timepoint [1] 304885 0
during period of hospital admission
Primary outcome [2] 305037 0
length of hospital stay as determined by review of hospital records
Timepoint [2] 305037 0
assessed during the period of hospitalisation
Secondary outcome [1] 343479 0
number of hospital readmissions determined using hospital records
Timepoint [1] 343479 0
within one month of hospital discharge after index admission
Secondary outcome [2] 343966 0
number of readmissions determined using hospital records
Timepoint [2] 343966 0
within six months of hospital discharge from index admission
Secondary outcome [3] 344783 0
number of complications e.g nosocomial infections determined using medical records
Timepoint [3] 344783 0
during period of hospital admission

Eligibility
Key inclusion criteria
All patients greater than or equal to 18 years of age who have confirmed influenza.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All gynecologic and surgical admissions

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Values will be presented as mean (standard deviation) or median (interquartile range) for
continuous variables and as number (percentage) for categorical variables where
appropriate. Student’s t test or MannWhitney test will be used to compare continuous
variables while Chi2 or Fisher’s exact test will test categorical variables as
appropriate. Multivariate logistic regression will be used to determine whether troponin
elevation during hospital admission predicts length of hospital stay, mortality,
complications during hospital admission or readmissions within one month or within 6
months following discharge after adjusting for confounders including age, gender, Charlson
index and preexistingcardiovascular disease.
Kaplan-Meier survival curves will be plotted and Log rank test will be used to determine
differences in survival according to troponin elevation during admission. All tests of
significance will be two-tailed and a p < 0.05 will be considered as statistically
significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2018
Actual
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10083 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 10084 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 21609 0
5042 - Bedford Park
Recruitment postcode(s) [2] 21610 0
5000 - Adelaide
Recruitment postcode(s) [3] 21611 0
5042 - Flinders University
Recruitment postcode(s) [4] 21612 0
5000 - Adelaide Bc

Funding & Sponsors
Funding source category [1] 298334 0
Hospital
Name [1] 298334 0
Flinders Medical Centre
Country [1] 298334 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive Bedford Park South Australia 5042
Country
Australia
Secondary sponsor category [1] 297449 0
None
Name [1] 297449 0
Address [1] 297449 0
Country [1] 297449 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299325 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 299325 0
Office for Research
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 299325 0
Australia
Date submitted for ethics approval [1] 299325 0
20/10/2017
Approval date [1] 299325 0
22/11/2017
Ethics approval number [1] 299325 0
285.17

Summary
Brief summary
Seasonal influenza is responsible for significant morbidity and mortality around the world. It may result in 200,000 to 500,00 deaths per year and numbers can be higher during pandemics. The frequency of myocardial involvement in influenza is variable with rates up to 10% having being reported in literature and depends upon the methods used to detect myocardial involvement. It is unclear how common asymptomatic cardiac involvement of influenza is although it has been reported as anywhere from 0 to 53% of cases. Although influenza is known to be associated with adverse cardiovascular outcomes but limited studies have studied relationship between troponin levels during hospital admission and clinical outcomes and it is unknown whether increased troponin levels can be used to predict clinical outcomes in these patients. The primary objective of this study will be to determine variables associated with adverse clinical outcomes in hospitalized patient admitted with influenza and other objective will be to determine whether troponin levels during admission correlates with length of hospital stay, complications during hospital admission and readmissions within 1 month and 6 months following discharge.
This study will involve only retrospective collection of data of all confirmed cases of influenza admitted in Flinders Medical Centre and Royal Adelaide Hospital between January 2014 and October 2017. The anticipated benefits are possibility of finding new variables, which can predict clinical outcomes in patients admitted with influenza and thus may help in directing strategies to high-risk patients in future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80062 0
Dr Yogesh Sharma
Address 80062 0
Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country 80062 0
Australia
Phone 80062 0
+61882046694
Fax 80062 0
Email 80062 0
[email protected]
Contact person for public queries
Name 80063 0
Yogesh Sharma
Address 80063 0
Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country 80063 0
Australia
Phone 80063 0
+61882046694
Fax 80063 0
Email 80063 0
[email protected]
Contact person for scientific queries
Name 80064 0
Yogesh Sharma
Address 80064 0
Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country 80064 0
Australia
Phone 80064 0
+61882046694
Fax 80064 0
Email 80064 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23590Study protocol  [email protected]
23591Statistical analysis plan  [email protected]
23592Informed consent form  [email protected]
23593Analytic code  [email protected]

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 374251-(Uploaded-20-11-2020-11-49-11)-Basic results summary.docx
Plain language summaryNo This study recruited 1846 patients over four influ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseClinical characteristics and outcomes of influenza A and B virus infection in adult Australian hospitalised patients.2020https://dx.doi.org/10.1186/s12879-020-05670-8
EmbasePrognostic impact of high sensitive troponin in predicting 30-day mortality among patients admitted to hospital with influenza.2021https://dx.doi.org/10.1016/j.ijcha.2020.100682
N.B. These documents automatically identified may not have been verified by the study sponsor.