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

ACTRN12622000058774

Ethics application status

Approved

Date submitted

7/01/2022

Date registered

18/01/2022

Date last updated

18/01/2022

Date data sharing statement initially provided

18/01/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Outcomes of patients aged over 90 years undergoing open heart surgery

Scientific title

Characteristics, comorbidity burden and outcomes in nonagenarian undergoing cardiac surgery: a multicentre observational study

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1273-0950

Trial acronym

Linked study record

Health condition

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

Cardiac surgery

Complications after cardiac surgery

Condition category

Condition code

Anaesthesiology

Anaesthetics

Surgery

Other surgery

Cardiovascular

Other cardiovascular diseases

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

In this study we will be observing complications after open cardiac surgery in patients aged > 90 years (nonagenarians) and the associated hospital complications and mortality. Patients undergoing surgery between 1 Jan 2012 and 31 Dec 2019 will be included.

As this is a retrospective study, there is no participant involvement. Only the de-identified hospital medical record of nonagenarians who have undergone open cardiac surgery will be reviewed.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Complications following open cardiac surgery.

Complications will be assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include anastomotic leak, infection, haemorrhage, death, etc. This outcome will be obtained by reviewing data-linkage to the hospital's medical records.

Timepoint [1]

Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.

Primary outcome [2]

Mortality following cardiac surgery.

Mortality will be defined as death after cardiac surgery.

This outcome will be obtained by reviewing data-linkage to the hospital's medical records or contact with the patient's general practitioner.

Timepoint [2]

Mortality will be collected within the index hospital admission, within 30 postoperative days, within 6 months post surgery, and long term mortality based on follow up.

Secondary outcome [1]

Type of surgery performed e.g coronary artery bypass graft surgery, or valvular surgery. This outcome will be obtained by reviewing data-linkage to the hospital's medical records.

Timepoint [1]

At the time of cardiac surgery during the inpatient hospital admission

Eligibility

Key inclusion criteria

Inclusion criteria will be nonagenarians (aged > 90 years < 100 years) who underwent cardiac surgery requiring a classic median sternotomy (i.e., “open heart surgery”) with or without the requirement for cardiopulmonary bypass.

Minimum age

90 Years

Maximum age

100 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria will be the following:
1. any patient less than 90 years of age
2. patients undergoing partial sternotomy for aortic valve procedures, sternotomy-free mini-thoracotomy for other procedures
3. patients undergoing transcatheter aortic valve implantation.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

Statistical analysis will be performed using IBM SPSS Statistics for Windows, version 23 (IBM Corp., 2015, Armonk, NY, USA) and Stata/SE 13.0 for Windows (StataCorp LP, Texas, USA, 2013). Data will be deidentified and the variable names encrypted ensuring all data are coded with numerical values to blind the collected variables’ characteristics to the statistician.

Data will be presented as mean ± standard deviation or median (1st?3rd quartiles) [Min:Max], or the number (percentile) for descriptive statistics. Only non-zero data points will be included in the calculation of descriptive statistics for numerical variables (e.g., drug doses, time periods).

Individual patient results will be simply listed for numerical variables with less than four non-zero data points. We will report this study using the STROBE guidelines for reporting observational studies.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/11/2021

Date of last participant enrolment

Anticipated

Actual

3/01/2022

Date of last data collection

Anticipated

Actual

6/01/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Warringal Private Hospital - Heidelberg

Recruitment hospital [3]

Epworth Richmond - Richmond

Recruitment hospital [4]

Epworth Eastern Hospital - Box Hill

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3121 - Richmond

Recruitment postcode(s) [3]

3128 - Box Hill

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

Department of Anaesthesia, Austin Hospital, 145 Studley Road, Heidelberg VIC, 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Department of Anaesthesia, Austin Hospital, 145 Studley Road, Heidelberg VIC, 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

L8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/04/2021

Approval date [1]

08/04/2021

Ethics approval number [1]

HREC21/30

Summary

Brief summary

Given the rarity of nonagenarians (age > 90 years) undergoing open cardiac surgery requiring cardiopulmonary bypass, there is a dearth of research describing their characteristics, comorbidity burden, perioperative course. Consequently, there is little evidence to guide and inform patient selection, clinical practice and enhance recovery pathways in this vulnerable patient cohort. 

Accordingly, this case series study aims to provide a detailed description of nonagenarians undergoing open cardiac surgery at four teaching hospitals in our state. Specifically, we aim to describe the demographics of nonagenarians undergoing cardiac surgery, their perioperative paradigm, their postoperative outcomes. In turn, this may help facilitate the selection of nonagenarians for surgery, help guide perioperative management, and allow for focused allocation of hospital resources.

Who is it for?
You may be eligible for this study if you are an adult patients over 90 years of age who underwent open cardiac surgery for for any indication at Austin Health, Warringal Private Hospital, Epworth Eastern Hospital or Epworth Richmond Hospital in Victoria, Australia

Study details
This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent cardiac surgery at the above Hospital from 1 January 2012 to 31 December 2019.

It is hoped that this research will help to provide a better understanding of outcomes associated with open cardiac surgery in this unique patient cohort.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Laurence Weinberg

Address

Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 94963800

Fax

laurence.weinberg@austin.org.au

Contact person for public queries

Name

Laurence Weinberg

Address

Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 94963800

Fax

laurence.weinberg@austin.org.au

Contact person for scientific queries

Name

Laurence Weinberg

Address

Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 94963800

Fax

laurence.weinberg@austin.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

As this is an observational study, patients have not provided consent for their data to be shared.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14605	Ethical approval	These can be obtained from the Principle investigater				383369-(Uploaded-07-01-2022-14-28-44)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Modern Cardiac Surgical Outcomes in Nonagenarians: A Multicentre Retrospective Observational Study.	2022	https://dx.doi.org/10.3389/fcvm.2022.865008

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