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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Luke A Perry, MBBS(Hons)
- 電話番号：+61395946666
- メール：luke.perry@monash.edu
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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.
他の名前：
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Days alive and at home at 30 days (DAH30)
時間枠：From the start of the index surgery until 30 days.
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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.
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From the start of the index surgery until 30 days.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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All-cause mortality at 180 days
時間枠：From the start of the index surgery until 180 days.
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Death from any cause.
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From the start of the index surgery until 180 days.
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Intensive care unit length of stay
時間枠：From the index postoperative admission to the ICU until the patient is discharged from the ICU.
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The cumulative duration spent admitted to the ICU the after the index surgery, measured in hours.
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From the index postoperative admission to the ICU until the patient is discharged from the ICU.
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Acute Kidney Injury (AKI)
時間枠：From the start of the index surgery until postoperative day 30.
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Any of (1) or (2) or (3), the KDIGO Criteria:
2. Stage 3 AKI
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From the start of the index surgery until postoperative day 30.
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Disability-free survival at 180 days
時間枠：From the start of the index surgery until 180 days.
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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.
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Major postoperative complications
時間枠：From the start of the index surgery until postoperative day 30.
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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.
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From the start of the index surgery until postoperative day 30.
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Quality of life at 180 days
時間枠：From baseline questionnaire until 180 days after the index surgery.
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Change in health-related quality of life from baseline, measured using the EuroQoL - 5 dimension - 5 level (EQ-5D-5L) score.
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From baseline questionnaire until 180 days after the index surgery.
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Days alive and at home at 180 days (DAH180)
時間枠：From the start of the index surgery until 180 days.
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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.
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From the start of the index surgery until 180 days.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maximum Vasoactive-Inotropic Score (VISmax) at 24h
時間枠：Measured at 0, 6, 12, and 24 hours from admission to ICU after index surgery, taking the maximum value.
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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.
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Duration of mechanical ventilation
時間枠：From initial intubation at the start of surgery until final extubation.
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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.
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From initial intubation at the start of surgery until final extubation.
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Red cell transfusion
時間枠：From the start of the index surgery until hospital discharge (i.e., occurring during the surgery or while an inpatient).
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Receipt of any allogenic red blood cell transfusion during the intraoperative or postoperative period, and the cumulative volume transfused, measure in mL.
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From the start of the index surgery until hospital discharge (i.e., occurring during the surgery or while an inpatient).
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Echocardiography utilization
時間枠：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.)
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Utilisation of formal diagnostic or bedside transesophageal or transthoracic echocardiography for any indication.
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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.)
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Work Productivity and Activity Impairment at 180 days
時間枠：From baseline questionnaire until 180 days after the index surgery.
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Change in the Work Productivity and Activity Impairment (WPAI): Heart Condition 2.0 score.
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From baseline questionnaire until 180 days after the index surgery.
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Safety Outcomes
時間枠：From insertion of the intervention until postoperative day 30.
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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.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 51507
- Pure ID: 648844307 (その他の識別子：Monash University)
- U1111-1337-6952 (その他の識別子：WHO UTN)
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