Pulmonary Artery Catheters in Cardiac Surgery

Официальное название

Pulmonary Artery Catheters in Adults Undergoing Cardiac Surgery (PUMA): an International, Multicentre, Bayesian, Non-Inferiority Randomised Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Days alive and at home at 30 days (DAH30) [Срок оценки: From the start of the index surgery until 30 days.]

Вторичные конечные точки (7)

• All-cause mortality at 180 days [Срок оценки: From the start of the index surgery until 180 days.]
• Intensive care unit length of stay [Срок оценки: From the index postoperative admission to the ICU until the patient is discharged from the ICU.]
• Acute Kidney Injury (AKI) [Срок оценки: From the start of the index surgery until postoperative day 30.]
• Disability-free survival at 180 days [Срок оценки: From the start of the index surgery until 180 days.]
• Major postoperative complications [Срок оценки: From the start of the index surgery until postoperative day 30.]
• Quality of life at 180 days [Срок оценки: From baseline questionnaire until 180 days after the index surgery.]
• Days alive and at home at 180 days (DAH180) [Срок оценки: From the start of the index surgery until 180 days.]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Undergoing cardiac surgery or surgery of the thoracic aorta

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07612683 · 51507 · Pure ID: 648844307 · U1111-1337-6952

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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