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Trial registered on ANZCTR


Registration number
ACTRN12623000522617p
Ethics application status
Submitted, not yet approved
Date submitted
8/05/2023
Date registered
19/05/2023
Date last updated
19/05/2023
Date data sharing statement initially provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of pulmonary artery catheters in low-risk heart surgery.
Scientific title
Pulmonary artery catheters in adults undergoing low risk cardiac surgery (The PUMA Pilot): a multicentre, randomised, controlled, consumer co-designed, Vanguard, pilot and feasibility clinical trial.
Secondary ID [1] 308825 0
None.
Universal Trial Number (UTN)
None.
Trial acronym
PUMA Pilot
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery 328783 0
Condition category
Condition code
Anaesthesiology 325793 325793 0 0
Other anaesthesiology
Cardiovascular 325794 325794 0 0
Coronary heart disease
Cardiovascular 326849 326849 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the intervention group will have a pulmonary artery catheter inserted by a cardiac anaesthetist prior to surgery. At both trial sites, standard procedure involves insertion of an Edwards Swan-Ganz catheter (3 lumen, 7.5 Fr) through an Arrow Multi-lumen Access Catheter (MAC) sheath (9 or 8.5 Fr), although the specific type of pulmonary artery catheter and method of insertion is at the discretion of the treating consultant cardiac anaesthetist. We place no restriction on how data derived from the pulmonary artery catheter is to be used by the treating clinicians (i.e. the study is pragmatic by design and does not include a protocol for goal-directed therapy). The duration of insertion for pulmonary artery catheters is at the sole discretion of the treating clinicians and will be different for each patient. The duration of insertion will be documented by the treating clinicians, cross referenced against the clinical record, and transcribed into case report forms.
Intervention code [1] 326048 0
Treatment: Devices
Comparator / control treatment
Patients in the control group will receive a central venous access device (CVAD) with direct central venous pressure monitoring. The CVAD will be inserted through a MAC sheath. The site and specific type of CVAD is at the discretion of the treating anaesthetist. All aspects of perioperative patient management will be at the discretion of the treating team. The treating clinicians can decide at any time to insert a pulmonary artery catheter if determined to be clinically indicated. We place no restriction on the use of other means of haemodynamic monitoring (e.g. transthoracic or transoesophageal echocardiography or pulse index continuous cardiac output (PiCCO) monitoring).

All aspects of participants’ perioperative management are at the discretion of the treating clinicians.

The duration of insertion for CVADs is at the sole discretion of the treating clinicians and will be different for each patient. The duration of insertion will be documented by the treating clinicians, cross referenced against the clinical record, and transcribed into case report forms.
Control group
Active

Outcomes
Primary outcome [1] 334694 0
Protocol Compliance: the proportion of participants who receive their assigned intervention and do not ‘cross-over’ (e.g. receive a pulmonary artery catheter if assigned to the control group), ascertained from the electronic medical record.
Timepoint [1] 334694 0
After randomisation occurs until first discharge from the intensive care unit.
Secondary outcome [1] 421750 0
Elligibility rate: the proportion of patients booked for cardiac surgery meeting all of the inclusion criteria and none of the exclusion criteria, ascertained from the cardiac surgery theatre booking lists and the Screening Log.
Timepoint [1] 421750 0
From the start of the trial until the 150th patient is recruited.
Secondary outcome [2] 421751 0
Recruitment proportion: the proportion of eligible patients who provide written informed consent and undergo randomisation, ascertained from the Screening Log and the Case Report Forms.
Timepoint [2] 421751 0
Measured at the end of the trial.
Secondary outcome [3] 421752 0
Recruitment rate: the number of participants recruited per site per 30 days, ascertained from the Screening Log.
Timepoint [3] 421752 0
Measured at the end of the trial.
Secondary outcome [4] 421753 0
Complete case report form proportion: the proportion of participants with complete paper and electronic case report forms.
Timepoint [4] 421753 0
Measured at the end of the trial.
Secondary outcome [5] 421755 0
Time in perioperative organ dysfunction (TPOD30) at 30 days: the combined duration of requirement of one or more of the following life-sustaining therapies: mechanical ventilation (not including non-invasive ventilation), vasopressor or inotrope therapy, mechanical circulatory support (e.g. extracorporeal membrane oxygenation or intra-aortic balloon pump), and continuous renal replacement therapy or new intermittent haemodialysis. This outcome will be assessed using data from the electronic medical record.
Timepoint [5] 421755 0
From admission to the Intensive Care Unit (ICU) until 30 days.
Secondary outcome [6] 421757 0
ICU Length of Stay: the number of hours from the index admission to ICU until the patient is discharged from the ICU, ascertained from the electronic medical records.
Timepoint [6] 421757 0
From the postoperative ICU admission until ICU discharge.
Secondary outcome [7] 421758 0
Duration of vasopressor or inotropic support: the total number of hours a patient is administered vasopressor and/or inotropic support. Vasopressor support is defined by any use of: noradrenaline, vasopressin, metaraminol, or phenylephrine. Inotrope support is defined by any use of: adrenaline, dobutamine, dopamine, levosimendan, milrinone, or isoprenaline, ascertained from the electronic medical records.
Timepoint [7] 421758 0
From admission to ICU until 7 days.
Secondary outcome [8] 421759 0
Cumulative dose of vasoactive drugs: Cumulative dose of vasopressor drugs, measured in noradrenaline equivalents using established methods, and inotropic drugs, ascertained from the electronic medical records.
Timepoint [8] 421759 0
From admission to ICU until 7 days.
Secondary outcome [9] 421760 0
Cumulative dose of diuretic drugs: cumulative dose (in mg) of frusemide administered orally or intravenously, ascertained from the electronic medical records.
Timepoint [9] 421760 0
From admission to ICU until 7 days.
Secondary outcome [10] 421763 0
Cumulative dose of albumin: cumulative dose (in g) of albumin administered, ascertained from the electronic medical records.
Timepoint [10] 421763 0
From admission to ICU until 7 days.
Secondary outcome [11] 421764 0
Net fluid balance: the cumulative volume of fluids administered to the patient from any source minus the cumulative measured volume of fluids removed from the patient by any source, ascertained from the electronic medical records.
Timepoint [11] 421764 0
At 24, 48, and 72 hours after surgery.
Secondary outcome [12] 421765 0
Peak lactate: the highest value recorded of plasma lactate levels in mmol/L, ascertained from the electronic medical records.
Timepoint [12] 421765 0
At 24, 48, and 72 hours after surgery.
Secondary outcome [13] 421766 0
Return to theatre: return to theatre for any cardiothoracic reoperation, ascertained from the electronic medical records.
Timepoint [13] 421766 0
From admission to ICU until 7 days.
Secondary outcome [14] 421767 0
Duration of mechanical ventilation: the number of hours from when the patient is first placed on mechanical ventilation in the operating theatre until final extubation (separate periods of intubation and mechanical ventilation are additive).
Timepoint [14] 421767 0
During the immediate postoperative ICU admission.
Secondary outcome [15] 421768 0
Re-intubation: re-insertion of an endotracheal tube after one is removed, ascertained from the electronic medical records.
Timepoint [15] 421768 0
During the immediate postoperative ICU admission.
Secondary outcome [16] 421769 0
Renal replacement therapy: the patient receives any form of renal replacement therapy which was not required preoperatively, ascertained from the electronic medical records.
Timepoint [16] 421769 0
From admission to ICU until 30 days.
Secondary outcome [17] 421770 0
Utilisation of echocardiography: the number of times each of the following are performed: bedside transthoracic echocardiography (TTE), formal diagnostic TTE performed by a sonographer or cardiologist, and transoesophageal echocardiography, ascertained from the electronic medical records.
Timepoint [17] 421770 0
From admission to ICU until 7 days.
Secondary outcome [18] 421771 0
Use of non-invasive cardiac output monitoring devices: use of any non-invasive cardiac output monitoring device (e.g. pulse countour devices [PiCCO], bioreactance devices, etc.), ascertained from the electronic medical records.
Timepoint [18] 421771 0
From admission to ICU until 7 days.
Secondary outcome [19] 421772 0
Readmission to the ICU: the patient is readmitted to the ICU after they have been discharged and transferred to another setting, ascertained from the electronic medical records.
Timepoint [19] 421772 0
From discharge from ICU until the patient is discharged from hospital.
Secondary outcome [20] 421773 0
Blood product transfusion: the volume in millilitres transfused of each of the following blood products: packed red blood cells, platelets, cryoprecipitate, fresh frozen plasma, and prothrombinex, ascertained from the electronic medical records.
Timepoint [20] 421773 0
From start of surgery until hospital discharge.
Secondary outcome [21] 421774 0
Serious infection: a composite of sepsis, deep sternal wound infection, graft site infection, radiographically and clinically proven pneumonia, and central-line associated blood stream infection (CLABSI), ascertained from the electronic medical records.
Timepoint [21] 421774 0
From admission to the ICU until discharge from hospital.
Secondary outcome [22] 421775 0
Post-operative atrial fibrillation: the development of new-onset and persistent (lasting at least 60 minutes or requiring any intervention) atrial fibrillation, ascertained from the electronic medical records.
Timepoint [22] 421775 0
From admission to ICU until 7 days have elapsed.
Secondary outcome [23] 421776 0
Acute Kidney Injury: acute kidney injury, defined by KDIGO Criteria, ascertained from the electronic medical records.
Timepoint [23] 421776 0
From start of surgery until hospital discharge.
Secondary outcome [24] 421777 0
All-cause mortality: death due to any cause, ascertained from the electronic medical records and by telephone interviews.
Timepoint [24] 421777 0
During the hospital admission, at 30 days, and at 90 days after surgery.
Secondary outcome [25] 421778 0
Days alive and at home: the number of days from admission to ICU until a set time has elapsed or the patient dies, minus the number of days the patient spent admitted to any hospital during this period (either during the index hospitalisation or any subsequent readmission.), ascertained from the electronic medical records and by telephone interviews.
Timepoint [25] 421778 0
At 30 and 90 days after surgery.
Secondary outcome [26] 421779 0
Hospital length of stay: the number of hours from admission to ICU until the patient is discharged from hospital, ascertained from the electronic medical records.
Timepoint [26] 421779 0
From admission to ICU until discharge from hospital.
Secondary outcome [27] 421780 0
Discharge destination: the type of place the patient is discharged to. Categories include: rehabilitation facility/step-down care, another hospital, the patient’s home, supported accommodation, nursing facility, or other, ascertained from the electronic medical records and by telephone interviews.
Timepoint [27] 421780 0
At hospital discharge.
Secondary outcome [28] 421783 0
Major adverse cardiac events: a composite of all-cause mortality, stroke, AMI, repeat revascularisation procedure, and readmission to hospital due to heart failure, ascertained from the electronic medical records and by telephone interviews.
Timepoint [28] 421783 0
At 30 days after surgery.
Secondary outcome [29] 421784 0
Major adverse kidney events: a composite of all-cause mortality, need for renal replacement therapy, and persistent renal dysfunction, ascertained from the electronic medical records and by telephone interviews.
Timepoint [29] 421784 0
At 30 days after surgery.
Secondary outcome [30] 421785 0
Change in quality of life: EuroQoL – 5 dimension – 5 level (EQ-5D-5L) score at followup less the EQ-5D-5L score at enrolment, ascertained by telephone interviews.
Timepoint [30] 421785 0
At 90 days after surgery.

Eligibility
Key inclusion criteria
1. Undergoing coronary artery bypass grafting or isolated surgical aortic valve replacement or repair
2. Age < 18 years old
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Emergency procedures where surgery must be performed within 24 hours of the decision to operate (or before the start of the next business day)
2. Repeat or ‘re-do’ procedures
3. EuroSCORE II >2%
4. Pulmonary hypertension defined by right ventricular systolic pressure > 35 mmHg
5. Any degree of right ventricle systolic dysfunction as identified by cardiology report on most recent preoperative transthoracic echocardiogram. May be identified by cardiologist reported right ventricular systolic dysfunction, TAPSE < 15mm, or RVFAC < 35%.
6. Severe left ventricular systolic impairment (ejection fraction <30%)
7. Right-heart structural abnormality (e.g. severe tricuspid or pulmonary stenosis or regurgitation, tumour, atrial or ventricular septal defect)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2023
Actual
Date of last participant enrolment
Anticipated
15/06/2023
Actual
Date of last data collection
Anticipated
15/09/2023
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24689 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 24690 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 40312 0
3050 - Parkville
Recruitment postcode(s) [2] 40313 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 313051 0
Charities/Societies/Foundations
Name [1] 313051 0
Heart Foundation
Country [1] 313051 0
Australia
Funding source category [2] 313805 0
Charities/Societies/Foundations
Name [2] 313805 0
ANZCA Foundation
Country [2] 313805 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan Street, Parkville, Victoria 3190
Country
Australia
Secondary sponsor category [1] 315636 0
None
Name [1] 315636 0
N/A
Address [1] 315636 0
N/A
Country [1] 315636 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312302 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 312302 0
300 Grattan Street
Parville, VIC 3052
Australia
Ethics committee country [1] 312302 0
Australia
Date submitted for ethics approval [1] 312302 0
08/02/2023
Approval date [1] 312302 0
Ethics approval number [1] 312302 0

Summary
Brief summary
Background

• Over 2 million people undergo heart surgery every year.
• An invasive monitoring device called a ‘pulmonary artery catheter’ can measure how well the heart pumps, and is commonly used in heart surgery patients
• Small studies suggest that pulmonary artery catheters may not benefit these patients, and may even lead to harm such as major bleeding and infection
• Some experts conclude that pulmonary artery catheters overcomplicate things and lead to unnecessary and risky treatment
• There has never been a high quality ‘randomised controlled trial’, so there is still uncertainty amongst doctors

Aims

• Our ultimate aim is to provide reliable evidence on whether heart surgery patients benefit from pulmonary artery catheters
• First, we must test whether a large-scale trial is feasible by starting with a small ‘pilot study’

Methods

• 150 patients undergoing low risk heart surgery will be eligible to participate
• After providing informed consent and prior to surgery, participants will be allocated at random to receive either a pulmonary artery catheter or a less invasive alternative in a 1-to-1 ratio
• We will record how smoothly the pilot study runs by collecting information on the number of patients we recruit, the number of times a person is switched from one strategy to another by their doctor, and how completely we can collect data and follow up patients
• We will also assess whether pulmonary artery catheters influence a range of clinical outcomes in the intensive care unit, general ward, and at home after patients are discharged.


Impact

• If the PUMA Pilot is successful, the research team will conduct a large-scale randomised clinical trial that could change global practice
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124170 0
Dr Luke Perry
Address 124170 0
Level 3, Department of Anaesthesia
Royal Melbourne Hospital
300 Grattan Street, Parkville VIC 3052
Australia
Country 124170 0
Australia
Phone 124170 0
+61 393427136
Fax 124170 0
Email 124170 0
Luke.Perry@mh.org.au
Contact person for public queries
Name 124171 0
Dr Luke Perry
Address 124171 0
Level 3, Department of Anaesthesia
Royal Melbourne Hospital
300 Grattan Street, Parkville VIC 3052
Australia
Country 124171 0
Australia
Phone 124171 0
+61 393427000
Fax 124171 0
Email 124171 0
Luke.Perry@mh.org.au
Contact person for scientific queries
Name 124172 0
Dr Luke Perry
Address 124172 0
Level 3, Department of Anaesthesia
Royal Melbourne Hospital
300 Grattan Street, Parkville VIC 3052
Australia
Country 124172 0
Australia
Phone 124172 0
+61 393427000
Fax 124172 0
Email 124172 0
Luke.Perry@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot and feasibility study.


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.