ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000473369

Ethics application status

Approved

Date submitted

20/03/2026

Date registered

16/04/2026

Date last updated

16/04/2026

Date data sharing statement initially provided

16/04/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Invasive monitoring with a pulmonary artery catheter for patients undergoing open heart surgery

Scientific title

Pulmonary Artery Catheters in Adults Undergoing Cardiac Surgery (PUMA): an International, Multicentre, Bayesian, Non-Inferiority Randomised Trial.

Additional trial identifiers [1]

None

Universal Trial Number (UTN)

U1111-1337-6952

Trial acronym

PUMA

Related trial records

Health condition

Health condition(s) studied:

Cardiac Surgery

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Anaesthesiology

Anaesthetics

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Pulmonary Artery Catheter (PAC) Group:

Participants randomized to the PAC group will have a PAC inserted according to local policies and procedures by an experienced clinician prior to the start of surgery.

Typically inserted via the internal jugular vein and ‘floated’ to the pulmonary artery via the right heart, PACs generate data on cardiac output and other cardiopulmonary parameters that can be used to guide treatment decisions in the perioperative period.

The specific type of PAC and method of insertion (including target insertion vessel and whether a vascular access sheath is used) is at the discretion of the treating consultant/attending cardiac anaesthesiologist.

There are no restrictions on how data derived from the PAC is used by the treating clinicians (i.e. the study is pragmatic by design and does not include a protocol for goal-directed therapy (GDT)).

The decision and timing of when to remove or replace the PAC is at the discretion of the relevant treating clinicians. The overall duration of use will be ascertained from review of medical records.

Intervention code [1]

Treatment: Devices

Description of the comparator or control

No-PAC Group:

Participants randomized to the no-PAC group will have a central venous catheter inserted according to local policies and procedures by an experienced clinician prior to the start of surgery.

Central venous catheters (CVCs), which follow the same insertion path but terminate ~25cm shallower at the cavoatrial junction, are less invasive and form part of standard care in many settings.

As with the PAC group, the attributes, method of insertion, and target vessel, as well as all other aspects of participants’ perioperative management, is at the discretion of treating clinicians.

The decision and timing of when to remove or replace the CVC is at the discretion of the relevant treating clinicians. The overall duration of use will be ascertained from review of medical records.

If the clinicians deem that crossover is necessary to ensure patient safety, a PAC can be inserted in patients allocated to the no-PAC group.

Control group

Active

Outcomes

Primary outcome [1]

Days Alive and at Home at postoperative day 30 (DAH30). This will be assessed as a composite outcome.

Timepoint [1]

Timing: from the start of the index surgery until 30 days.

Secondary outcome [1]

All-cause mortality.

Timepoint [1]

Timing: from the start of the index surgery until 180 days.

Secondary outcome [2]

Intensive care unit length of stay

Timepoint [2]

Timing: from the index postoperative admission to the ICU until the patient is discharged from the ICU.

Secondary outcome [3]

Acute Kidney Injury (AKI).

Timepoint [3]

Timing: from the start of the index surgery until postoperative day 30.

Secondary outcome [4]

Disability-free survival.

Timepoint [4]

Timing: from the start of the index surgery 180 days.

Secondary outcome [5]

Major postoperative complication (composite).

Timepoint [5]

Timing: from arrival in ICU after index surgery until postoperative day 30.

Secondary outcome [6]

Maximum Vasoactive-Inotropic Score (VISmax).

Timepoint [6]

Timing: from admission to ICU after index surgery until 24 hours have elapsed.

Secondary outcome [7]

Duration of mechanical ventilation.

Timepoint [7]

Timing: from initial intubation until final extubation.

Secondary outcome [8]

Red cell transfusion.

Timepoint [8]

Timing: from the start of the index surgery until hospital discharge.

Secondary outcome [9]

Echocardiography utilisation.

Timepoint [9]

Timing: during the index postoperative ICU admission.

Secondary outcome [10]

Quality of life at 180 days.

Timepoint [10]

Timing: from baseline questionnaire until 180 days after the index surgery.

Secondary outcome [11]

Days Alive and at Home at 180 days (DAH180).

Timepoint [11]

Timing: from the start of the index surgery until 180 days.

Secondary outcome [12]

Serious Adverse Device Effects (SADE)

Timepoint [12]

Timing: between insertion of the device and 24 h after device removal.

Secondary outcome [13]

Central Line Associated Bloodstream Infection (CLABSI)

Timepoint [13]

Timing: between admission to ICU after the primary surgery and 48 h after the last central venous access is removed.

Secondary outcome [14]

Postoperative atrial fibrillation.

Timepoint [14]

Timing: between arrival in ICU after primary surgery and postoperative day 30.

Secondary outcome [15]

Pulmonary embolism.

Timepoint [15]

Timing: between arrival in ICU after primary surgery and postoperative day 30.

Eligibility

Key inclusion criteria

• Age >= 18 years

• Undergoing cardiac surgery or surgery of the thoracic aorta

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

• Predicted operative mortality >=3% based on the EuroSCORE II

• Emergency surgery, defined as surgery that must be performed within 24 hours of the decision to operate or before the start of the next business day, whichever is sooner

• Severe left ventricular systolic impairment (ejection fraction <30%)

• Pulmonary hypertension, defined hierarchically as:
o Mean pulmonary artery pressure (mPAP) = 20 mmHg based on the most recent
formal right heart catheterisation (RHC) study conducted pre-operatively; else, if
no RHC performed
o Peak tricuspid regurgitant velocity (TRV) = 2.9 m.s-1 on the most recent pre-
operative transthoracic echocardiogram; else, if TRV not reported
o Right ventricular systolic pressure (RVSP) = 40 mmHg on the most recent pre-
operative transthoracic echocardiogram

• Right ventricular systolic impairment. May be identified by cardiologist reported right ventricular systolic dysfunction, TAPSE < 15mm, or RVFAC < 35% on pre-operative transthoracic echocardiography

• Endovascular-only procedures

• Cardiac transplantation

• Contraindication to pulmonary artery catheterisation (e.g. severe tricuspid or pulmonary stenosis, right heart tumour, large atrial or ventricular septal defects)

• Contraindication to transesophageal echocardiography (e.g. prior oesophagectomy, oesophageal pathology (tumour, stricture, perforation, diverticulum), active upper GI bleed)

• Patients previously enrolled and randomized in PUMA.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Due to the use of an independent statistician for random sequence generation, trial personnel, participants, and treating clinicians will be unable to determine or predict treatment allocation until after the randomisation form is submitted by study personnel.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be randomised in a 1:1 ratio to the no-PAC or the PAC strategy using a secure, central, web-based randomisation system. Randomisation will use randomly permuted blocks of varying size (2 or 4), stratified by site and surgical urgency (elective vs urgent), to maintain balance within centres and across urgency strata. The initial randomisation sequence will be generated by an independent statistician and uploaded into the EDC system.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/07/2026

Actual

Date of last participant enrolment

Anticipated

31/12/2030

Actual

Date of last data collection

Anticipated

30/06/2031

Actual

Sample size

Target

1600

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Department of Health, Disability and Ageing - Medical Research Future Fund

Address [1]

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Heart Foundation

Address [2]

Country [2]

Australia

Primary sponsor type

University

Name

Monash University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee A

Ethics committee address [1]

https://monashhealth.org/research/resources/resource-library/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/02/2026

Approval date [1]

02/04/2026

Ethics approval number [1]

HREC/126197/MonH-2026-520535

Summary

Brief summary

Open heart surgery is performed more than 2 million times each year worldwide. During and after surgery, doctors often use invasive devices to monitor the heart and blood vessels. One of these devices, the pulmonary artery catheter, provides detailed information about how the heart is functioning. Despite being widely used, it is still unclear whether this device actually helps patients recover better, because it has never been properly tested in a high-quality randomised trial.

The PUMA study will address this question by randomly assigning adults undergoing open heart surgery to receive either a pulmonary artery catheter or standard care without one. We will compare outcomes that matter most to patients, including measures chosen with input from people with lived experience. This study will help determine whether routine use of this device improves recovery, safety, and overall outcomes after open heart surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Luke Perry

Address

Level 5, Victorian Heart Hospital, 631 Blackburn Road, Clayton, Victoria 3168

Country

Australia

Phone

+613 9594 6666

Fax

[email protected]

Contact person for public queries

Name

Luke Perry

Address

Level 5, Victorian Heart Hospital, 631 Blackburn Road, Clayton, Victoria 3168

Country

Australia

Phone

+613 9594 6666

Fax

[email protected]

Contact person for scientific queries

Name

Luke Perry

Address

Level 5, Victorian Heart Hospital, 631 Blackburn Road, Clayton, Victoria 3168

Country

Australia

Phone

+613 9594 6666

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• All de-identified individual participant data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
A finite period of: 2 years

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically