Pulmonary Artery Catheters in Cardiac Surgery (PUMA)
Pulmonary Artery Catheters in Adults Undergoing Cardiac Surgery (PUMA): an International, Multicentre, Bayesian, Non-Inferiority Randomised 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:
- 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Luke A Perry, MBBS(Hons)
- Número de teléfono: +61395946666
- Correo electrónico: luke.perry@monash.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
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.
Otros nombres:
|
|
Experimental: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Days alive and at home at 30 days (DAH30)
Periodo de tiempo: 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.
|
From the start of the index surgery until 30 days.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
All-cause mortality at 180 days
Periodo de tiempo: From the start of the index surgery until 180 days.
|
Death from any cause.
|
From the start of the index surgery until 180 days.
|
|
Intensive care unit length of stay
Periodo de tiempo: 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.
|
From the index postoperative admission to the ICU until the patient is discharged from the ICU.
|
|
Acute Kidney Injury (AKI)
Periodo de tiempo: From the start of the index surgery until postoperative day 30.
|
Any of (1) or (2) or (3), the KDIGO Criteria:
2. Stage 3 AKI
|
From the start of the index surgery until postoperative day 30.
|
|
Disability-free survival at 180 days
Periodo de tiempo: 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%. |
From the start of the index surgery until 180 days.
|
|
Major postoperative complications
Periodo de tiempo: 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.
|
From the start of the index surgery until postoperative day 30.
|
|
Quality of life at 180 days
Periodo de tiempo: 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.
|
From baseline questionnaire until 180 days after the index surgery.
|
|
Days alive and at home at 180 days (DAH180)
Periodo de tiempo: 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.
|
From the start of the index surgery until 180 days.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum Vasoactive-Inotropic Score (VISmax) at 24h
Periodo de tiempo: Measured at 0, 6, 12, and 24 hours from admission to ICU after index surgery, taking the maximum value.
|
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] |
Measured at 0, 6, 12, and 24 hours from admission to ICU after index surgery, taking the maximum value.
|
|
Duration of mechanical ventilation
Periodo de tiempo: From initial intubation at the start of surgery until final extubation.
|
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.
|
From initial intubation at the start of surgery until final extubation.
|
|
Red cell transfusion
Periodo de tiempo: From the start of the index surgery until hospital discharge (i.e., occurring during the surgery or while an inpatient).
|
Receipt of any allogenic red blood cell transfusion during the intraoperative or postoperative period, and the cumulative volume transfused, measure in mL.
|
From the start of the index surgery until hospital discharge (i.e., occurring during the surgery or while an inpatient).
|
|
Echocardiography utilization
Periodo de tiempo: 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.)
|
Utilisation of formal diagnostic or bedside transesophageal or transthoracic echocardiography for any indication.
|
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.)
|
|
Work Productivity and Activity Impairment at 180 days
Periodo de tiempo: From baseline questionnaire until 180 days after the index surgery.
|
Change in the Work Productivity and Activity Impairment (WPAI): Heart Condition 2.0 score.
|
From baseline questionnaire until 180 days after the index surgery.
|
|
Safety Outcomes
Periodo de tiempo: From insertion of the intervention until postoperative day 30.
|
1. Serious Adverse Device Events (SADEs) A mechanical or thrombotic complication caused by a PAC or CVC, that:
2. Central Line Associated Bloodstream Infection (CLABSI) 3. Postoperative atrial fibrillation 4. Pulmonary embolism 5. All-cause mortality |
From insertion of the intervention until postoperative day 30.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 51507
- Pure ID: 648844307 (Otro identificador: Monash University)
- U1111-1337-6952 (Otro identificador: WHO UTN)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .