[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640289":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":32,"responsibleParty":39,"collaborators":41,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":32,"enrollmentInfo":56,"targetDuration":32,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":71,"whyStopped":32,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":32},{"fullName":5,"class":6},"Monash University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulmonary Artery Catheter Group","ACTIVE_COMPARATOR","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\u002Fattending 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.",[13],"Device: Pulmonary Artery Catheter",{"label":15,"type":16,"description":17,"interventionNames":18},"No Pulmonary Artery Catheter (No-PAC) Group","EXPERIMENTAL","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.",[19],"Device: No Pulmonary Artery Catheter (No-PAC)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","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.",[9],[27],"Swan-Ganz Catheter",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"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.",[15],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Luke A Perry, MBBS(Hons)","CONTACT","+61395946666","luke.perry@monash.edu",{"type":40,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[42,44],{"name":43,"class":6},"Medical Research Future Fund",{"name":45,"class":6},"National Heart Foundation, Australia","100640289","pulmonary-artery-catheters-in-cardiac-surgery-100640289",false,"NCT07612683","Pulmonary Artery Catheters in Cardiac Surgery","Pulmonary Artery Catheters in Adults Undergoing Cardiac Surgery (PUMA): an International, Multicentre, Bayesian, Non-Inferiority Randomised Trial.","PUMA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing cardiac surgery or surgery of the thoracic aorta\n\nExclusion Criteria:\n\n* Predicted operative mortality ≥ 3% based on the EuroSCORE II\n* 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\n* Severe left ventricular systolic impairment (ejection fraction \\\u003C30%)\n* Pulmonary hypertension, defined hierarchically as:\n\n  * 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\n  * 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\n  * Right ventricular systolic pressure (RVSP) ≥ 40 mmHg on the most recent pre-operative transthoracic echocardiogram\n* Right ventricular systolic impairment. May be identified by cardiologist reported right ventricular systolic dysfunction, TAPSE \\\u003C 15mm, or RVFAC \\\u003C 35% on pre-operative transthoracic echocardiography\n* Endovascular-only procedures\n* Cardiac transplantation\n* Contraindication to pulmonary artery catheterisation (e.g. severe tricuspid or pulmonary stenosis, right heart tumour, large atrial or ventricular septal defects)\n* Contraindication to transesophageal echocardiography (e.g. prior oesophagectomy, oesophageal pathology (tumour, stricture, perforation, diverticulum), active upper GI bleed)\n* Patients previously enrolled and randomized in PUMA.","ALL","18 Years",{"count":57,"type":58},1600,"ESTIMATED","INTERVENTIONAL",[61],"NA","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.\n\nThe main questions it will answer are:\n\n1. 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?\n2. How do the 2 strategies compare for kidney injury, major complications, survival, disability-free survival, quality of life, and healthcare use?\n\nResearchers 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.\n\nParticipants will:\n\nBe 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\n\nNo extra in-person study visits or additional tests are required as part of this trial.",[64],"Cardiac Surgery",[64,66,67,68,69,70],"Cardiac Anesthesiology","Pulmonary Artery Catheters","Hemodynamic Monitoring","Pragmatic Clinical Trials","Intensive Care Medicine","NOT_YET_RECRUITING","2026-05-24",{"date":74,"type":75},"2026-05-29","ACTUAL",{"date":77,"type":58},"2026-06",{"date":79,"type":58},"2030-01",{"name":5,"class":6}]