Pulmonary Artery Catheters in Cardiac Surgery

NCT07612683 | Not Yet Recruiting DMC

• 3 other identifiers: 51507Pure ID: 648844307U1111-1337-6952
• Study Type: interventional
• Target: 1,600
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.How do the 2 strategies compare for kidney injury, major complications, survival, disability-free survival, quality of life, and healthcare use?

Conditions

Cardiac Surgery

Keywords

Cardiac Surgery; Cardiac Anesthesiology; Pulmonary Artery Catheters; Hemodynamic Monitoring; Pragmatic Clinical Trials; Intensive Care Medicine

Outcome Measures

Primary Outcomes (1)

• Days alive and at home at 30 days (DAH30)

  The number of days from the start of surgery until 30 days have elapsed or the patient dies, minus: (1) the number of days the patient spent admitted to any hospital during this period (either during the index hospitalisation or any subsequent readmission); and (2) the number of days the patient spent at a location other than their home (e.g. time spent at an inpatient rehabilitation facility, a nursing home, or supported accommodation). For patients who died within the 30-day period, DAH30 is automatically set to zero.

  From the start of the index surgery until 30 days.

Secondary Outcomes (7)

• All-cause mortality at 180 days

  From the start of the index surgery until 180 days.

• Intensive care unit length of stay

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

• Acute Kidney Injury (AKI)

  From the start of the index surgery until postoperative day 30.

• Disability-free survival at 180 days

  From the start of the index surgery until 180 days.

• Major postoperative complications

  From the start of the index surgery until postoperative day 30.

Other Outcomes (6)

• Maximum Vasoactive-Inotropic Score (VISmax) at 24h

  Measured at 0, 6, 12, and 24 hours from admission to ICU after index surgery, taking the maximum value.

• Duration of mechanical ventilation

  From initial intubation at the start of surgery until final extubation.

• Red cell transfusion

  From the start of the index surgery until hospital discharge (i.e., occurring during the surgery or while an inpatient).

Study Arms (2)

Pulmonary Artery Catheter Group

ACTIVE COMPARATOR

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. 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 aneesthesiologist. 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.

Device: Pulmonary Artery Catheter

No Pulmonary Artery Catheter (No-PAC) Group

EXPERIMENTAL

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. 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.

Device: No Pulmonary Artery Catheter (No-PAC)

Interventions

Pulmonary Artery Catheter DEVICE

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.

Also known as: Swan-Ganz Catheter

Pulmonary Artery Catheter Group

No Pulmonary Artery Catheter (No-PAC) DEVICE

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.

No Pulmonary Artery Catheter (No-PAC) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Undergoing cardiac surgery or surgery of the thoracic aorta

You may not qualify if:

• 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:
• 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
• Peak tricuspid regurgitant velocity (TRV) ≥ 2.9 m.s-1 on the most recent pre-operative transthoracic echocardiogram;45,46 else, if TRV not reported
• 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.

Sponsors & Collaborators

• Monash University: lead
• Medical Research Future Fund: collaborator
• National Heart Foundation, Australia: collaborator

Central Study Contacts

Luke A Perry, MBBS(Hons)

CONTACT

+61395946666; luke.perry@monash.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share