Trial Review

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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
Date results information 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] 306145 0
None
Universal Trial Number (UTN)
U1111-1273-0950
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery 324842 0
Complications after cardiac surgery 324843 0
Condition category
Condition code
Anaesthesiology 322282 322282 0 0
Anaesthetics
Surgery 322283 322283 0 0
Other surgery
Cardiovascular 322284 322284 0 0
Other cardiovascular diseases
Cardiovascular 322285 322285 0 0
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] 322554 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330044 0
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] 330044 0
Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.
Primary outcome [2] 330045 0
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] 330045 0
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] 404709 0
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] 404709 0
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?
No
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
18
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21442 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 21443 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [3] 21444 0
Epworth Richmond - Richmond
Recruitment hospital [4] 21445 0
Epworth Eastern Hospital - Box Hill
Recruitment postcode(s) [1] 36343 0
3084 - Heidelberg
Recruitment postcode(s) [2] 36344 0
3121 - Richmond
Recruitment postcode(s) [3] 36345 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 310488 0
Hospital
Name [1] 310488 0
Austin Health
Country [1] 310488 0
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] 311653 0
None
Name [1] 311653 0
Address [1] 311653 0
Country [1] 311653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310117 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 310117 0
L8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084
Ethics committee country [1] 310117 0
Australia
Date submitted for ethics approval [1] 310117 0
01/04/2021
Approval date [1] 310117 0
08/04/2021
Ethics approval number [1] 310117 0
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 116534 0
A/Prof Laurence Weinberg
Address 116534 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 116534 0
Australia
Phone 116534 0
+61 3 94963800
Fax 116534 0
Email 116534 0
[email protected]
Contact person for public queries
Name 116535 0
A/Prof Laurence Weinberg
Address 116535 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 116535 0
Australia
Phone 116535 0
+61 3 94963800
Fax 116535 0
Email 116535 0
[email protected]
Contact person for scientific queries
Name 116536 0
A/Prof Laurence Weinberg
Address 116536 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 116536 0
Australia
Phone 116536 0
+61 3 94963800
Fax 116536 0
Email 116536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
14605Ethical approvalThese 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
SourceTitleYear of PublicationDOI
EmbaseModern Cardiac Surgical Outcomes in Nonagenarians: A Multicentre Retrospective Observational Study.2022https://dx.doi.org/10.3389/fcvm.2022.865008
N.B. These documents automatically identified may not have been verified by the study sponsor.