Pulmonary Artery Catheters in Adults Undergoing Cardiac Surgery [PUMA]: an International, Multicentre, Bayesian, Non-Inferiority Randomised Trial (NCT07612683)

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.

Trial phase

Phase 4

Trial participation type

This trial has been designed for the Clinical Research of a Device.

Principal investigator

A/Prof Tim Coulson

Key inclusion data

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