NCT Number: NCT07612683
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Time frame: From the start of the index surgery until 30 days.
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 180 days.
Death from any cause.
Time frame: From the index postoperative admission to the ICU until the patient is discharged from the ICU.
The cumulative duration spent admitted to the ICU the after the index surgery, measured in hours.
Time frame: From the start of the index surgery until postoperative day 30.
Any of (1) or (2) or (3), the KDIGO Criteria:
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
Time frame: From the start of the index surgery until 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 postoperative day 30.
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 baseline questionnaire until 180 days after the index surgery.
Change in health-related quality of life from baseline, measured using the EuroQoL - 5 dimension - 5 level (EQ-5D-5L) score.
Time frame: From the start of the index surgery until 180 days.
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: Measured at 0, 6, 12, and 24 hours from admission to ICU after index surgery, taking the maximum value.
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: From initial intubation at the start of surgery until final extubation.
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 the start of the index surgery until hospital discharge (i.e., occurring during the surgery or while an inpatient).
Receipt of any allogenic red blood cell transfusion during the intraoperative or postoperative period, and the cumulative volume transfused, measure in mL.
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.)
Utilisation of formal diagnostic or bedside transesophageal or transthoracic echocardiography for any indication.
Time frame: From baseline questionnaire until 180 days after the index surgery.
Change in the Work Productivity and Activity Impairment (WPAI): Heart Condition 2.0 score.
Time frame: From insertion of the intervention until postoperative day 30.
A mechanical or thrombotic complication caused by a PAC or CVC, that:
Contact information is provided by the study sponsor or research team.
Monash University
Other
Pulmonary Artery Catheters in Adults Undergoing Cardiac Surgery (PUMA): an International, Multicentre, Bayesian, Non-Inferiority Randomised Trial.
Acronym: PUMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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