Pulmonary Artery Catheters in Adults Undergoing Cardiac Surgery (PUMA): an International, Multicentre, Bayesian, Non-Inferiority Randomised Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,600
- 主要终点
- Days alive and at home at 30 days (DAH30)
研究概览
简要总结
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:
- 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?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Undergoing cardiac surgery or surgery of the thoracic aorta
排除标准
- •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.
研究组 & 干预措施
Pulmonary Artery Catheter Group
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.
干预措施: Pulmonary Artery Catheter (Device)
No Pulmonary Artery Catheter (No-PAC) Group
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.
干预措施: No Pulmonary Artery Catheter (No-PAC) (Device)
结局指标
主要结局
Days alive and at home at 30 days (DAH30)
时间窗: 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.
次要结局
- 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.)
- Quality of life at 180 days(From baseline questionnaire until 180 days after the index surgery.)
- Days alive and at home at 180 days (DAH180)(From the start of the index surgery until 180 days.)