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NOT YET RECRUITING
NCT07612683
NA

Pulmonary Artery Catheters in Cardiac Surgery

Sponsor: Monash University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether avoiding a pulmonary artery catheter (PAC), a type of invasive monitoring tool, is no worse than using one in adults undergoing open heart surgery. The main questions it will answer are: 1. Does avoiding routine PAC use lead to recovery that is no worse than routine PAC use, measured by days alive and at home during the first 30 days after surgery? 2. How do the 2 strategies compare for kidney injury, major complications, survival, disability-free survival, quality of life, and healthcare use? Researchers will compare routine PAC use with no routine PAC use (using a standard central venous catheter instead) to see whether patients recover as well without a PAC. Participants will: Be randomly assigned to have either a PAC or no PAC at the start of their surgery Receive usual care from their treating team Be followed up at about 30 days and 180 days after surgery, mainly by telephone and review of medical records No extra in-person study visits or additional tests are required as part of this trial.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1600

Start Date

2026-06

Completion Date

2030-01

Last Updated

2026-05-29

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Pulmonary Artery Catheter

Inserted via the internal jugular vein and 'floated' to the pulmonary artery via the right heart, pulmonary artery catheters (PACs) generate data on cardiac output and other cardiopulmonary parameters including pulmonary hemodynamics, biventricular function, mixed venous oxygen saturations, and filling pressures.

DEVICE

No Pulmonary Artery Catheter (No-PAC)

Patients in the no-PAC arm must not receive a PAC. They can, however, receive a central venous catheter. Central venous catheters, 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.