Pulmonary Artery Catheters in Cardiac Surgery

ConditionCardiac Surgery

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMonash University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Undergoing cardiac surgery or surgery of the thoracic aorta

Disqualifiers

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%)

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

Trial design

Design model

Parallel

Treatments tested in this trial

Pulmonary Artery Catheter
Device
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.
No Pulmonary Artery Catheter (No-PAC)
Device
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.

Treatment groups

1,600 Participants

are divided into 2 treatment groups

Group A: Pulmonary Artery Catheter GroupActive comparator 1 intervention

Group B: No Pulmonary Artery Catheter (No-PAC) GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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.

Other outcomes

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.)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Monash University

Lead sponsor

Medical Research Future Fund

Collaborator

National Heart Foundation, Australia

Collaborator

Source ClinicalTrials.gov

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