Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001160123
Ethics application status
Approved
Date submitted
19/07/2019
Date registered
20/08/2019
Date last updated
20/08/2019
Date data sharing statement initially provided
20/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predicting survival after veno-arterial extra corporeal membrane oxygenation (VA-ECMO) in the context of cardiac surgery.
Scientific title
Outcomes after initiation of veno-arterial extra corporeal membrane oxygenation (VA-ECMO) in post cardiac surgery patients and predictors of survival.
Secondary ID [1] 298693 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shock 313709 0
Extra corporeal membrane oxygenation 313710 0
Survival 313711 0
Cardiac surgery 313712 0
Condition category
Condition code
Cardiovascular 312122 312122 0 0
Other cardiovascular diseases
Anaesthesiology 312123 312123 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No involvement is required of participants; eligible patients will be identified from the medical records at the Austin Hospital
Duration of observation per participant will be for 30 days after initiation of extracorporeal membrane oxygen after cardiac surgery. Data will be obtained from the period between 1 August 2001 and 30 September 2016.
Intervention code [1] 315052 0
Diagnosis / Prognosis
Comparator / control treatment
Survivors
Control group
Active

Outcomes
Primary outcome [1] 320774 0
Survival to hospital discharge or 30 days after VA-ECMO initiation. This will be assessed using the medical records and from the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZCTS) database.
Timepoint [1] 320774 0
Discharge or 30 days after VA-ECMO initiation.
Primary outcome [2] 320775 0
Proportion of patients with successful decannulation (i.e. the ability to remove ECMO cannulae at least once). This will be assessed using the medical records and from the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZCTS) database.
Timepoint [2] 320775 0
Discharge or 30 days after VA-ECMO initiation.
Primary outcome [3] 320776 0
Proportion of patients with pooled major complications within 30 days of ECMO initiation: cannulation site bleeding, limb ischaemia, retroperitoneal haematoma, inadequate oxygenation, transfusion of four or more red blood cells, return to theatre. These will be assessed using the medical records and from the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZCTS) database.
Timepoint [3] 320776 0
Discharge or 30 days after VA-ECMO initiation.
Secondary outcome [1] 372799 0
Difference in age amongst survivors vs. non-survivors, identified from the medical record.
Timepoint [1] 372799 0
Immediately before initiation of VA-ECMO
Secondary outcome [2] 372832 0
Difference in EuroScore I amongst survivors vs. non-survivors identified from the medical record.
Timepoint [2] 372832 0
Immediately before initiation of VA-ECMO
Secondary outcome [3] 372833 0
Difference in logEuroScore I amongst survivors vs. non-survivors, identified from the medical record.
Timepoint [3] 372833 0
Immediately before initiation of VA-ECMO
Secondary outcome [4] 373121 0
Difference in AusScore amongst survivors vs. non-survivors, identified from the medical record.
Timepoint [4] 373121 0
Immediately before initiation of VA-ECMO
Secondary outcome [5] 373122 0
Difference in SAVE score amongst survivors vs. non-survivors, identified from the medical record
Timepoint [5] 373122 0
Immediately before initiation of VA-ECMO
Secondary outcome [6] 373123 0
Difference in SOFA score amongst survivors vs. non-survivors, identified from the medical record.
Timepoint [6] 373123 0
Immediately before initiation of VA-ECMO
Secondary outcome [7] 373124 0
Difference in peak VIS score amongst survivors vs. non-survivors, identified from the medical record.
Timepoint [7] 373124 0
Immediately before initiation of VA-ECMO
Secondary outcome [8] 373125 0
Difference in time to VA-ECMO initiation amongst survivors vs. non-survivors, identified from the medical record.
Timepoint [8] 373125 0
Immediately before initiation of VA-ECMO
Secondary outcome [9] 373126 0
Difference in peak lactate concentration amongst survivors vs. non-survivors, identified from the medical record.
Timepoint [9] 373126 0
Immediately before initiation of VA-ECMO
Secondary outcome [10] 373127 0
Difference in age amongst survivors and non-survivors, identified from the medical record.
Timepoint [10] 373127 0
Within 24 hours of VA-ECMO initiation (excluding death within 24 hours).
Secondary outcome [11] 373128 0
Difference in peak creatinine amongst survivors and non-survivors, identified from the medical record.
Timepoint [11] 373128 0
Within 24 hours of VA-ECMO initiation (excluding death within 24 hours).
Secondary outcome [12] 373129 0
Difference in peak troponin amongst survivors and non-survivors, identified from the medical record.
Timepoint [12] 373129 0
Within 24 hours of VA-ECMO initiation (excluding death within 24 hours).
Secondary outcome [13] 373130 0
Difference in peak alanine transferase amongst survivors and non-survivors, identified from the medical record.
Timepoint [13] 373130 0
Within 24 hours of VA-ECMO initiation (excluding death within 24 hours).
Secondary outcome [14] 373131 0
Difference in peak lactate amongst survivors and non-survivors, identified from the medical record.
Timepoint [14] 373131 0
Within 24 hours of VA-ECMO initiation (excluding death within 24 hours).
Secondary outcome [15] 373132 0
Difference in nadir lactate amongst survivors and non-survivors, identified from the medical record.
Timepoint [15] 373132 0
Within 24 hours of VA-ECMO initiation (excluding death within 24 hours).
Secondary outcome [16] 373133 0
Difference in average hourly urine output amongst survivors and non-survivors, identified from the medical record.
Timepoint [16] 373133 0
Within 24 hours of VA-ECMO initiation (excluding death within 24 hours).
Secondary outcome [17] 373134 0
Difference in age amongst survivors and non-survivors, identified from the medical record.
Timepoint [17] 373134 0
Within 48 hours of VA-ECMO initiation (excluding death within 48 hours).
Secondary outcome [18] 373135 0
Difference in peak creatinine amongst survivors and non-survivors, identified form the medical record.
Timepoint [18] 373135 0
Within 48 hours of VA-ECMO initiation (excluding death within 48 hours).
Secondary outcome [19] 373136 0
Difference in peak troponin amongst survivors and non-survivors, identified form the medical record.
Timepoint [19] 373136 0
Within 48 hours of VA-ECMO initiation (excluding death within 48 hours).
Secondary outcome [20] 373137 0
Difference in peak alanine transferase amongst survivors and non-survivors, identified from the medical record.
Timepoint [20] 373137 0
Within 48 hours of VA-ECMO initiation (excluding death within 48 hours).
Secondary outcome [21] 373138 0
Difference in peak lactate amongst survivors and non-survivors, identified from the medical record.
Timepoint [21] 373138 0
Within 48 hours of VA-ECMO initiation (excluding death within 48 hours).
Secondary outcome [22] 373139 0
Difference in nadir lactate amongst survivors and non-survivors, identified from the medical record.
Timepoint [22] 373139 0
Within 48 hours of VA-ECMO initiation (excluding death within 48 hours).
Secondary outcome [23] 373140 0
Difference in average urine output amongst survivors and non-survivors., identified from the medical record.
Timepoint [23] 373140 0
Within 48 hours of VA-ECMO initiation (excluding death within 48 hours).

Eligibility
Key inclusion criteria
Requiring veno-arterial extra-corporeal membrane oxygenation (VA-ECMO)
Post cardiotomy initiation of VA-ECMO
Adults (>18 years old)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Transfer to another facility whilst on VA-ECMO
Institution of VA-ECMO prior to cardiopulmonary bypass

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The primary outcome will involve descriptive statistics only. Data will be presented as mean (SD) or median (IQR) depending on distribution of normality.

For the secondary outcomes, planned statistical analysis will be logistic regression modelling using survival as the key independent variable taking into account limitations set by number of survival rates and patient data. Univariate analysis of each potential variable will be initially performed. If patient data does not allow for logistic regression modelling, adjustments for multiplicity will be performed.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
19/02/2018
Date of last participant enrolment
Anticipated
Actual
22/04/2019
Date of last data collection
Anticipated
Actual
19/07/2019
Sample size
Target
100
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14294 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 27289 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 303244 0
Hospital
Name [1] 303244 0
Austin Hospital
Country [1] 303244 0
Australia
Primary sponsor type
Individual
Name
Dr Raymond Hu
Address
Department of Anaesthesia
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 303451 0
None
Name [1] 303451 0
Address [1] 303451 0
Country [1] 303451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303788 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 303788 0
Ethics committee country [1] 303788 0
Australia
Date submitted for ethics approval [1] 303788 0
28/08/2017
Approval date [1] 303788 0
16/02/2018
Ethics approval number [1] 303788 0
LNR/18/Austin/67

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94810 0
Dr Raymond Hu
Address 94810 0
Department of Anaesthesia
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 94810 0
Australia
Phone 94810 0
+61 3 9496 3800
Fax 94810 0
Email 94810 0
[email protected]
Contact person for public queries
Name 94811 0
Raymond Hu
Address 94811 0
Department of Anaesthesia
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 94811 0
Australia
Phone 94811 0
+61 3 9496 3800
Fax 94811 0
Email 94811 0
[email protected]
Contact person for scientific queries
Name 94812 0
Raymond Hu
Address 94812 0
Department of Anaesthesia
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 94812 0
Australia
Phone 94812 0
+61 3 9496 3800
Fax 94812 0
Email 94812 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
For patient privacy, no individual participant data will be available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3268Ethical approval    377938-(Uploaded-29-07-2019-00-03-53)-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
No additional documents have been identified.