ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

None

Universal Trial Number (UTN)

Trial acronym

None

Linked study record

None

Health condition

Health condition(s) or problem(s) studied:

Influenza

myocarditis

myocardial infarction

pneumonia

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Cardiovascular

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]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

in-hospital mortality assessed by review of hospital records.

Timepoint [1]

during period of hospital admission

Primary outcome [2]

length of hospital stay as determined by review of hospital records

Timepoint [2]

assessed during the period of hospitalisation

Secondary outcome [1]

number of hospital readmissions determined using hospital records

Timepoint [1]

within one month of hospital discharge after index admission

Secondary outcome [2]

number of readmissions determined using hospital records

Timepoint [2]

within six months of hospital discharge from index admission

Secondary outcome [3]

number of complications e.g nosocomial infections determined using medical records

Timepoint [3]

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?

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)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment hospital [2]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5042 - Bedford Park

Recruitment postcode(s) [2]

5000 - Adelaide

Recruitment postcode(s) [3]

5042 - Flinders University

Recruitment postcode(s) [4]

5000 - Adelaide Bc

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

Flinders Medical Centre, Flinders Drive Bedford Park South Australia 5042

Country [1]

Australia

Primary sponsor type

Hospital

Name

Flinders Medical Centre

Address

Flinders Drive Bedford Park South Australia 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)

Ethics committee address [1]

Office for Research
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/10/2017

Approval date [1]

22/11/2017

Ethics approval number [1]

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

Dr Yogesh Sharma

Address

Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042

Country

Australia

Phone

+61882046694

Fax

Yogesh.Sharma@sa.gov.au

Contact person for public queries

Name

Yogesh Sharma

Address

Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042

Country

Australia

Phone

+61882046694

Fax

Yogesh.Sharma@sa.gov.au

Contact person for scientific queries

Name

Yogesh Sharma

Address

Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042

Country

Australia

Phone

+61882046694

Fax

Yogesh.Sharma@sa.gov.au

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			374251-(Uploaded-20-11-2020-11-49-11)-Basic results summary.docx
Plain language summary	No		This study recruited 1846 patients over four influ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Clinical characteristics and outcomes of influenza A and B virus infection in adult Australian hospitalised patients.	2020	https://dx.doi.org/10.1186/s12879-020-05670-8
Embase	Prognostic impact of high sensitive troponin in predicting 30-day mortality among patients admitted to hospital with influenza.	2021	https://dx.doi.org/10.1016/j.ijcha.2020.100682

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically