An interventional study of Pulmonary Artery Catheter and No Pulmonary Artery Catheter (No-PAC) in Cardiac Surgery, sponsored by Monash University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Monash University · Not applicable, Interventional, and Treatment
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:
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.
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.
Monash University is the lead sponsor of 83 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pulmonary hypertension, defined hierarchically as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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
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.
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.
Time frame: From the start of the index surgery until 30 days.
All-cause mortality at 180 days
Death from any cause.
Time frame: From the start of the index surgery until 180 days.
Intensive care unit length of stay
The cumulative duration spent admitted to the ICU the after the index surgery, measured in hours.
Time frame: From the index postoperative admission to the ICU until the patient is discharged from the ICU.
Acute Kidney Injury (AKI)
Any of (1) or (2) or (3), the KDIGO Criteria: 1. Stage 1 AKI a. increase in plasma creatinine to between 1.5 and 1.9-fold baseline; or a. urine output \< 0.5 ml.kg-1.h-1 for 6-12 h 2. Stage 2 AKI b. increase in plasma creatinine to between 2.0 and 2.9-fold baseline; or c. urine output \< 0.5 ml.kg-1.h-1 for ≥ 12 h 2\. Stage 3 AKI 1. increase in plasma creatinine to ≥ 3-fold baseline; or 2. increase in plasma creatinine to ≥ 353.6 μmol.l-1 (4.0 mg.dl-1); or 3. initiation of renal replacement therapy
Time frame: From the start of the index surgery until postoperative day 30.
Disability-free survival at 180 days
Survival and freedom from new or worsening disability. Disability is measured using the 12-item World Health Organisation Disability Assessment Scale 2.0 (WHODAS 2.0) and defined as below: New Disability: for patients without baseline disability (WHODAS 2.0 \<25%), a WHODAS 2.0 at follow-up of ≥ 25%. Worsening Disability: for patients with baseline disability (WHODAS 2.0 ≥25%), a WHODAS 2.0 at follow-up equal to their baseline score plus ≥10%.
Time frame: From the start of the index surgery until 180 days.
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.
Time frame: From the start of the index surgery until postoperative day 30.
Quality of life at 180 days
Change in health-related quality of life from baseline, measured using the EuroQoL - 5 dimension - 5 level (EQ-5D-5L) score.
Time frame: From baseline questionnaire until 180 days after the index surgery.
Days alive and at home at 180 days (DAH180)
The number of days from the start of surgery until 180 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 180-day period, DAH180 is automatically set to zero.
Time frame: From the start of the index surgery until 180 days.
Maximum Vasoactive-Inotropic Score (VISmax) at 24h
Vasoactive-inotropic score (VIS) is a validated scoring system to quantify the weighted sum of all administered inotropes and vasopressors. VISmax is calculated using the maximum dosing rates during the first 24 hours after surgery using the following formula, adapted from the work of Koponen et al: VIS=dopamine dose \[μg kg-1 min-1\]+dobutamine \[μg kg-1 min-1\]+100×epinephrine dose \[μg kg-1 min-1\]+50×levosimendan dose \[μg kg-1 min-1\]+10×milrinone dose \[μg kg-1 min-1\]+10 000×vasopressin \[units kg-1 min-1\]+100×norepinephrine dose \[μg kg-1 min-1\]
Time frame: Measured at 0, 6, 12, and 24 hours from admission to ICU after index surgery, taking the maximum value.
Duration of mechanical ventilation
The number of hours from when the patient is first placed on mechanical ventilation in the operating theatre until final extubation (separate periods of intubation and mechanical ventilation are additive), measured in hours.
Time frame: From initial intubation at the start of surgery until final extubation.
Red cell transfusion
Receipt of any allogenic red blood cell transfusion during the intraoperative or postoperative period, and the cumulative volume transfused, measure in mL.
Time frame: From the start of the index surgery until hospital discharge (i.e., occurring during the surgery or while an inpatient).
Echocardiography utilization
Utilisation of formal diagnostic or bedside transesophageal or transthoracic echocardiography for any indication.
Time frame: During the index postoperative ICU admission (i.e., from when the patient is transferred to the ICU from the operating room and until the patient is first discharged from ICU to a ward bed.)
Work Productivity and Activity Impairment at 180 days
Change in the Work Productivity and Activity Impairment (WPAI): Heart Condition 2.0 score.
Time frame: From baseline questionnaire until 180 days after the index surgery.
Safety Outcomes
1\. Serious Adverse Device Events (SADEs) A mechanical or thrombotic complication caused by a PAC or CVC, that: 1. is not better explained as a complication of the surgical procedure; and 2. results in mortality or serious morbidity, defined as: 1. life-threatening injury; or 2. need for invasive treatment; or 3. significant delay in care; or 4. prolongation of ICU or hospital admission 2\. Central Line Associated Bloodstream Infection (CLABSI) 3\. Postoperative atrial fibrillation 4\. Pulmonary embolism 5\. All-cause mortality
Time frame: From insertion of the intervention until postoperative day 30.
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Plan to share: No
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