Cardiac Surgery
Conditions
Keywords
Cardiac Surgery, Cardiac Anesthesiology, Pulmonary Artery Catheters, Hemodynamic Monitoring, Pragmatic Clinical Trials, Intensive Care Medicine
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. 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.
Detailed 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.
Interventions
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.
DEVICENo 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.
Sponsors
Monash University
Medical Research Future Fund
National Heart Foundation, Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days alive and at home at 30 days (DAH30) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality at 180 days | From the start of the index surgery until 180 days. | Death from any cause. |
| Intensive care unit length of stay | 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. |
| Acute Kidney Injury (AKI) | From the start of the index surgery until postoperative day 30. | 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 |
| Disability-free survival at 180 days | 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%. |
| Major postoperative complications | 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. |
| Quality of life at 180 days | 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. |
| Days alive and at home at 180 days (DAH180) | 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. |
Contacts
CONTACTLuke A Perry, MBBS(Hons)
Outcome results
None listed