PUMA trial

The Pulmonary Artery Catheters in Adults Undergoing Low-Risk Cardiac Surgery (PUMA) trial is a large, multicentre randomised trial comparing the use of a pulmonary artery catheter with a simpler, less invasive central venous catheter in patients undergoing cardiac surgery.

Principal investigator: Dr Luke Perry (Vic)

Trial summary

Background

Landmark trials in sepsis, acute respiratory distress syndrome, general intensive care and major noncardiac surgery demonstrated no benefit, or even harm, from pulmonary artery catheters. No randomised trials have been conducted in cardiac surgery, and evidence from observational studies is mixed, resulting in significant equipoise and variation in practice.

The PUMA Pilot Trial recruited 150 participants across three Australian sites. It exceeded all pre-specified feasibility criteria, was completed within six months, demonstrated increased acute kidney injury with pulmonary artery catheters (PACs), and involved no emergency crossover from a central venous catheter (CVC) to a pulmonary artery catheter.

Primary objective

To determine whether perioperative management without a PAC is non-inferior to perioperative management with a PAC with respect to days spent alive and at home by postoperative day 30 (DAH30) among adults undergoing low-risk cardiac surgery.

Study title

Pulmonary Artery Catheters in Adults Undergoing Low-Risk Cardiac Surgery (PUMA): an International, Multicentre, Bayesian, Non-Inferiority, Parallel (1:1), Open-Label, Blinded-Endpoint, Randomised Trial.

Setting

At least 20 cardiac surgery centres in Australia and internationally.

Eligible sites must have used pulmonary artery catheters in at least 50 cardiac surgeries during the previous 12 months.

Population

Inclusion criteria

Adults aged 18 years or older undergoing cardiac surgery or surgery of the thoracic aorta.

Exclusion criteria

Predicted operative mortality of 3% or greater according to EuroSCORE II.
Emergency surgery, defined as a decision-to-operation time of less than 24 hours.
Pulmonary hypertension, defined as mean pulmonary artery pressure greater than 20 mmHg if right heart catheterisation has been performed; otherwise, peak tricuspid regurgitation velocity of 2.9 m/s or greater if reported; otherwise, right ventricular systolic pressure of 40 mmHg or greater.
Right ventricular systolic dysfunction.
Severe left ventricular systolic dysfunction, defined as an ejection fraction of less than 30%.
Contraindication to pulmonary artery catheterisation.
Contraindication to transoesophageal echocardiography.
Cardiac transplantation.
Endovascular-only procedures.
Previous enrolment and randomisation in PUMA.

Sample size

1,600 participants, with potential extension to 2,000 participants following adaptive recalibration.

Interventions

PAC group
Insertion of a pulmonary artery catheter before the start of surgery.

No-PAC group
Insertion of a central venous catheter, without insertion of a pulmonary artery catheter, before the start of surgery.

Perioperative management
All other aspects of perioperative management, including how information generated through the interventions is used, will be at the sole discretion of the treating clinicians. Emergency treatment crossover is permitted at the discretion of the treating clinicians.

Outcomes

Primary outcome

Days spent alive and at home by postoperative day 30 (DAH30).

Secondary outcomes

Intensive care unit length of stay.
Acute kidney injury.
Major postoperative complications, comprising a composite of operative mortality, disabling stroke, non-fatal cardiac arrest, postoperative myocardial infarction, severe acute kidney injury, sepsis, deep incisional or organ-space infection, or pneumonia.
All-cause mortality at 180 days.
Disability-free survival, assessed using WHODAS 2.0, at 180 days.

Tertiary outcomes

Vasoactive-inotropic score at 24 hours.
Duration of mechanical ventilation.
Volume of red-cell transfusion at intensive care unit discharge.
Echocardiography use during the intensive care unit admission.

Economic outcomes

Quality of life, assessed using EQ-5D-5L, at 180 days.
Days spent alive and at home at 180 days.
Total healthcare expenditure associated with the primary inpatient admission.
Work productivity and activity impairment at 180 days.

Safety outcomes

Adverse device events.
Central line-associated bloodstream infections.
Postoperative atrial fibrillation.
Pulmonary embolism.
All-cause mortality.

Assessments

Telephone follow-up will occur at 30 days and 180 days after the index surgery. Participants will complete baseline EQ-5D-5L, WHODAS 2.0 and WPAI 2.0 questionnaires in person. These questionnaires will be repeated by telephone at 180 days after the index surgery.

No additional laboratory investigations, imaging investigations or in-person reviews are required as part of this pragmatic trial.

Statistical approach

Statistical framework
Bayesian.

Hypothesis testing
Hierarchical non-inferiority and superiority testing for the primary outcome.

Adaptive recalibration
The sample size will be adaptively recalibrated during an interim analysis conducted after 50% of participants have been enrolled.

Sub-studies

Heterogeneity of Treatment Effects.
Health Economic Evaluation.
Environmental Impact Assessment.
Mechanistic Evaluation.
Mixed Methods Appraisal of Clinical Decision-making.

Study duration

Four years.

Funding

Australian Government Department of Health, Disability and Ageing Medical Research Future Fund 2024 Clinical Trials Activity Grant
Amount: A$3,676,411.60
Grant ID: GNT/2045244

Australian National Heart Foundation 2025 Vanguard Grant
Amount: A$150,000
Grant ID: GNT/110578-2025_VGc

Principal investigators

Dr Luke A Perry (chief principal investigator)
Associate Professor Lachlan F Miles
Professor Philip Peyton
Associate Professor Lisa Q Rong
Professor Silvana Marasco
Professor Jayme Bennetts
Professor Julian A Smith
Professor Mario Gaudino
Professor Christobel Saunders AO
Associate Professor Emily See
Associate Professor Ary Serpa Neto
Professor Stephen Nicholls
Ms Paige Druce
Professor Michael Bailey
Professor Zanfina Ademi
Dr Sanne Peters

Trial registration

ClinicalTrials.gov: NCT07612683

Australian New Zealand Clinical Trials Registry: ACTRN12626000473369

Endorsements

Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA CTN).
Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS).

Trial sponsor

Monash University, Australia.

Ethics review

Australian Human Research Ethics Committee: Monash Health

International sites must obtain full ethics, governance and regulatory approval in accordance with all applicable local requirements.

Publications

Perry LA, Segal R, Larobina M, Bellomo R, Smith JA, Sin J, Danial K, McLean ARD, Rong LQ, Gaudino M, Schwann T, Palumbo M, O’Halloran L, Chee B, Patel J, Silvers A, Bennetts J, Marasco S, Coulson TG, Royse A, See E, Miles LF; ANZCA Clinical Trials Network. Pulmonary artery catheters or central venous catheters for cardiac surgery: the PUMA Pilot randomised clinical trial. Anaesthesia. 2026. doi: 10.1111/anae.70282.

Media releases

Patients co-design world-first $3.7 million PUMA clinical trial set to simplify heart surgery across Australia - Published January 2026

Anaesthetists lead global trial to simplify open heart surgery - Published January 2026

PUMA trial: Redefining best practice in heart monitoring after open-heart surgery - Published January 2026

Trial start-up meeting

The PUMA start-up meeting will take place at the ANZCA CTN workshop on Saturday 22 August.

How to get involved

Please email the study team if you are interested in being involved or would like further information about the PUMA trial.