Pulmonary Artery Catheters in Cardiac Surgery (PUMA)

Monash University

Status: Not yet enrolling

Conditions: Cardiac Surgery

Treatments: Device: No Pulmonary Artery Catheter (No-PAC); Device: Pulmonary Artery Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT07612683

Pure ID: 648844307 (Other Identifier)

U1111-1337-6952 (Other Identifier)

51507

Details and patient eligibility

About

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.

Full description

PUMA is an international, multicentre, Bayesian, non-inferiority, parallel-group (1:1), open-label, blinded-endpoint randomized trial evaluating pulmonary artery catheter (PAC) use in adults undergoing cardiac surgery or surgery of the thoracic aorta. The trial is being conducted at tertiary cardiac surgery centres in Australia and internationally.

Pulmonary artery catheters remain widely used in cardiac surgery, but no high-quality randomized trials have established whether their routine use improves patient-centred outcomes in this setting. Observational studies have reported conflicting results, major trials in other critically ill populations have not shown benefit, and practice varies substantially between hospitals and clinicians. The PUMA pilot trial demonstrated the feasibility of a larger randomized trial.

Eligible adults will be randomly assigned before surgery to either insertion of a PAC or insertion of a central venous catheter without a PAC. All other perioperative management decisions, including how haemodynamic information is used and whether crossover is required for clinical reasons, are left to the treating clinicians, consistent with the pragmatic design of the trial.

The primary objective is to determine whether avoiding routine PAC use is noninferior to routine PAC use with respect to days alive and at home at 30 days after surgery (DAH30). Secondary analyses will compare the 2 strategies for major postoperative complications, acute kidney injury, intensive care unit length of stay, mortality, disability-free survival, quality of life, and healthcare utilization. Under the prespecified treatment-policy framework, the primary estimand is the median treatment effect on DAH30 for assignment to no-PAC versus PAC, regardless of treatment crossover, with a noninferiority margin of 1 day.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,600 participants in 2 patient groups

Pulmonary Artery Catheter Group

Active Comparator group

Description:

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.

Treatment:

Device: Pulmonary Artery Catheter

No Pulmonary Artery Catheter (No-PAC) Group

Experimental group

Description:

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.

Treatment:

Device: No Pulmonary Artery Catheter (No-PAC)