This is the STAGING server for testing & practice only.

Trial Summary

PUMA is an international, multicentre, Bayesian, parallel assignment (1:1), open-label, blinded-endpoint, consumer and community co-designed, non-inferiority randomized trial of pulmonary artery catheter use in adults undergoing cardiac surgery.

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 randomized trials have been conducted in cardiac surgery, and evidence from observational studies is mixed, resulting in significant equipoise and practice variation.

The PUMA Pilot Trial (n=150; 3 Australian sites) exceeded all pre-specified feasibility criteria, was completed within 6 months, demonstrated increased AKI with pulmonary artery catheters (PACs), and involved no emergency crossover from central venous catheter (CVC) to pulmonary artery catheter.

Primary Objective

To determine if perioperative management without a PAC is noninferior 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.

Setting

≥20 cardiac surgery centres in Australia and internationally.

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

Population

Inclusion:

  • Adults (aged ≥18 years) undergoing cardiac surgery or surgery of the thoracic aorta

Exclusion:

  • Predicted operative mortality ≥3% by EuroSCORE II
  • Emergency surgery (decision-to-operation time <24 h)
  • Pulmonary hypertension (mPAP > 20 mmHg if RHC; else peak TRV ≥ 2.9 m/s if reported; else RVSP ≥ 40 mmHg)
  • Right ventricular systolic dysfunction
  • Severe left ventricular systolic dysfunction (ejection fraction <30%)
  • Contraindication to pulmonary artery catheterisation
  • Contraindication to transesophageal echocardiography
  • Cardiac transplantation
  • Endovascular-only procedures
  • Prior enrolment and randomisation to PUMA

Sample Size: 1,600 (with potential extension to 2,000 following adaptive recalibration).

Interventions

PAC Group: insertion of a PAC prior to surgical start.

No-PAC Group: insertion of a central venous catheter (and not a pulmonary artery catheter) prior to surgical start.

Perioperative Management: all other aspects of perioperative management, including how data generated using the interventions is used, is at the sole discretion of treating clinicians. Emergency treatment crossover is permitted at the discretion of treating clinicians.

Outcomes

Primary Outcome:

  • DAH30

Secondary Outcomes:

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

Tertiary Outcomes:

  • Vasoactive-inotropic score (VIS) at 24 h
  • Duration of mechanical ventilation
  • Volume of red cell transfusion at ICU discharge
  • Echocardiography utilisation during the ICU admission

Economic Outcomes:

  • Quality of life (EQ-5D-5L) at 180 d
  • DAH at 180 d
  • Total healthcare expenditure of the primary inpatient admission
  • Work productivity and activity impairment at 180 d

Safety Outcomes:

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

Assessments

Telephone review will occur at 30 days and 180 days post index surgery. Participants will complete baseline EQ-5D-5L, WHODAS 2.0, and WPAI 2.0 questionnaires at baseline (in-person) and by phone at 180 days post index surgery.

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

Statistical Approach

Statistical Framework: Bayesian.

Hypothesis Testing: hierarchical non-inferiority and superiority testing for the primary outcome.

Adaptive Recalibration: sample size adaptively recalibrated at the interim analysis at 50% enrolment.

Sub-studies

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

Study Duration

4 years.

Funding

Grant Opportunity: Australian Government Department of Health, Disability and Ageing Medical Research Future Fund (MRFF) 2024 Clinical Trials Activity grant (GNT/2045244).

Grant Opportunity: Australian National Heart Foundation 2025 Vanguard Grant (GNT/110578-2025_VGc).

Trial Registration

clinicaltrials.gov: NCT07612683

ANZCTR: 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
Approval Number: HREC/126197/MonH-2026-520535

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

Contact

Public Queries
PUMA Program Manager
admin@pumatrial.org

Scientific Queries
Dr Luke Perry
PUMA Coordinating Principal Investigator
luke.perry@monash.edu