Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000222549
Ethics application status
Approved
Date submitted
30/06/2023
Date registered
6/03/2024
Date last updated
6/03/2024
Date data sharing statement initially provided
6/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Atrial pacing for optimisation of cardiac output in patients post cardiac surgery
Scientific title
Atrial pacing for optimisation of cardiac output in patients post cardiac surgery
Secondary ID [1] 310019 0
Nil
Universal Trial Number (UTN)
Trial acronym
APACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac surgery
 330545 0
Condition category
Condition code
Cardiovascular 327387 327387 0 0
Coronary heart disease
Cardiovascular 327388 327388 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study evaluating patients with pacing wires and pulmonary artery catheters post cardiac surgery. This will be performed after the patient has been admitted to the intensive care unit and the treating Intensivist feels the patient is clinically stable and euvolaemic.

Intensive care doctor will administer the intervention. There will be a paper form for each patient with the schedule of heart rates, duration and instructions.

Evaluating the Cardiac Output response to Different pacing rates (60, 75, 90, 110.)
HR set at 90 (atrially paced) and then Cardiac Index measured at 10 minutes
Then HR at 60 for 10 minutes and measure cardiac index at 10 minutes
Return to 90 for 5 minutes (baseline)
Then HR at 75 for 10 minutes and measure cardiac index at 10 minutes
Return to 90 for 5 minutes
then HR set to 110 for 10 minutes and cardiac index measured at 10 minutes
In total the intervention and measurement period will take 50 minutes

Where Atrio-Ventricular conduction block exists, patients will have both atrial and Ventricular wires, The same 4 heart rates will be selected - 60, 75,. 90, 110 and the same process adhered to but will require 2 chamber pacing so the pacing box setting will be DDD rather than AAI.

In order to compare to ventricular pacing alone a convenience subset of 20 patients with atrial and ventricular wires will have ventricular pacing alone at 75 and 90 beats per minute to compare with the corresponding pacing with the atrial wire. This is a secondary exploratory outcome. These patients will be chosen based on availability of staff. This will occur immediately after the first set. The duration of 75 and 90 will be the same as the rest of cohort.

The study member applying the intervention will remain at the bedside for the duration of the intervention and ensure adherence to the protocol
Intervention code [1] 326440 0
Treatment: Devices
Comparator / control treatment
No control group
Patients are their own controls as the different heart rates are evaluated within the same patient
90 is the reference comparator (baseline)
Control group
Active

Outcomes
Primary outcome [1] 335259 0
Cardiac Index - measured using a swan ganz catheter with continuous cardiac output monitoring function
Timepoint [1] 335259 0
Measured 10 minutes after selecting set heart rate
Secondary outcome [1] 423651 0
Blood pressure - measured from arterial line (invasive blood pressure monitor)
Timepoint [1] 423651 0
10 minutes post selecting heart rate
Secondary outcome [2] 423652 0
Vasopressor dose - required yes/no and dose in micrograms/kg/min from infusion pumps
Timepoint [2] 423652 0
10 minutes post selected heart rate
Secondary outcome [3] 423653 0
Arrhythmias - recorded by medical and nurse staff on bedside flow chart (ie direct observation and monitors)
Timepoint [3] 423653 0
Recorded at any period during the study intervention and 30 minutes post
Secondary outcome [4] 431046 0
Cardiac Index with Ventricular pacing alone - only at HR of 75 and 90 for ventricular pacing - measured using the swan ganz catheter
Timepoint [4] 431046 0
Measured at 10 minutes post set HR of 90 and then 10 minutes post set HR of 75

Eligibility
Key inclusion criteria
1. Post cardiac surgery
2. Presence of pulmonary artery catheter and pacing wires
3. Over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treating clinician feels the intervention should not be applied due to haemodynamic stability or other concern
Absence of pacing wire or pulmonary artery catheter
Baseline (intrinsic) tachycardia >90

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not required - within patient study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All patients will start at a HR of 90 as a baseline
Then pre-printed forms will be provided by an research coordinator not involved in patient care or the intervention procedure with random allocation of the order of subsequent set heart rates of 60, 75 or 110. (this is not a randomised controlled trial but the order of applying the heart rate will be varied between patients using a simple sequence generated using the REDCAP simple randomisation list)
All patients receive the same intervention, only the order change and in between each change the set HR returns to 90 so that all changes will be from baseline
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/03/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 40707 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 314197 0
Hospital
Name [1] 314197 0
Sir Charles Gairdner Hospital
Country [1] 314197 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave, Nedlands, Western Australia 6009
Country
Australia
Secondary sponsor category [1] 316116 0
None
Name [1] 316116 0
Address [1] 316116 0
Country [1] 316116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313324 0
Sir Charles Gairdner and Osborne Park Hospital Ethics Committee
Ethics committee address [1] 313324 0
Ethics committee country [1] 313324 0
Australia
Date submitted for ethics approval [1] 313324 0
03/07/2023
Approval date [1] 313324 0
16/01/2024
Ethics approval number [1] 313324 0

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

Contacts
Principal investigator
Name 127734 0
Dr Bradley Wibrow
Address 127734 0
Sir Charles Gairdner Hopsital Intensive Care UnitHospital AveNedlandsWA 6009
Country 127734 0
Australia
Phone 127734 0
+61 422410689
Fax 127734 0
Email 127734 0
[email protected]
Contact person for public queries
Name 127735 0
Bradley Wibrow
Address 127735 0
Sir Charles Gairdner Hopsital Intensive Care UnitHospital AveNedlandsWA 6009
Country 127735 0
Australia
Phone 127735 0
+61 422410689
Fax 127735 0
Email 127735 0
[email protected]
Contact person for scientific queries
Name 127736 0
Bradley Wibrow
Address 127736 0
Sir Charles Gairdner Hopsital Intensive Care UnitHospital AveNedlandsWA 6009
Country 127736 0
Australia
Phone 127736 0
+61 422410689
Fax 127736 0
Email 127736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
outcome data
When will data be available (start and end dates)?
2-48 months post completion
Available to whom?
scientific community
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
Via the Principal investigator - [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



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.