Pulmonary Artery Catheters in Cardiac Surgery (PUMA)

有源比较器：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.

设备：Pulmonary Artery Catheter

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.

其他名称：

• Swan-Ganz Catheter

实验性的：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.

设备：No 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.

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.

All-cause mortality at 180 days

Death from any cause.

Intensive care unit length of stay

The cumulative duration spent admitted to the ICU the after the index surgery, measured in hours.

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

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%.

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.

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.

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.

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]

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.

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.

Echocardiography utilization

Utilisation of formal diagnostic or bedside transesophageal or transthoracic echocardiography for any indication.

Work Productivity and Activity Impairment at 180 days

Change in the Work Productivity and Activity Impairment (WPAI): Heart Condition 2.0 score.

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