Early Identification and Prediction of Right Ventricular Dysfunction and Failure in Critically Ill Patients: An Observational Non-Interventional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU
研究概览
简要总结
RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes.
However, so far, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU. The investigator's primary hypothesis is that the prevalence of abnormal RV pressure waveform occurs in more than 50% of cardiac surgical patients throughout their hospitalization. Those patients with abnormal RV pressure waveform will be more prone to post-operative complications related to RV dysfunction and failure in the OR and ICU.
详细描述
Right ventricular (RV) dysfunction is mostly associated to a decrease in contractility, right ventricular pressure overload or right ventricular volume overload. RV dysfunction can occur in a number of clinical scenarios in the intensive care unit (ICU) and operating room (OR): pulmonary embolism, acute respiratory distress syndrome (ARDS), septic shock, RV infarction, and in pulmonary hypertensive patients undergoing cardiac surgery.
Unfortunately, identifying which patients will develop RV dysfunction and then progress towards RV failure have proven difficult. One of the reasons for delaying the diagnosis of RV dysfunction could be the lack of uniform definition, especially in the perioperative period. Echocardiographic definitions of RV dysfunction have been described: RV fractional area change (RVFAC) < 35 %, tricuspid annular plane systolic excursion (TAPSE) < 16 mm, tissue Doppler S wave velocity <10 cm/s, RV ejection fraction (RVEF) <45% and RV dilation. However, echocardiographic indices alone are insufficient in describing RV function. The diagnosis of fulminant RV failure is more easily recognised as a combination of echocardiographic measures, compromised hemodynamic measures and clinical presentation. RV dysfunction is inevitably associated with absolute or relative pulmonary hypertension because of the anatomic and physiological connection between the RV and pulmonary vascular system. The gold standard for measuring pulmonary pressure is still the pulmonary artery catheter. However, RV output can initially be preserved despite of pulmonary hypertension. It is therefore mandatory that early, objective, continuous, easily obtainable and subclinical indices of RV dysfunction are found and validated to initiate early treatment of this disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, age 18 and older, undergoing cardiac surgery and receiving standard of care monitoring utilizing a pulmonary artery catheter.
排除标准
- •Emergency surgery or inability to obtain consent
- •Concomitant diseases such as pericardial constriction, congenital heart disease, severe valvular regurgitation, right ventricular systolic dysfunction, or right ventricular infarction.
结局指标
主要结局
Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU
时间窗: From thermodilution catheter insertion until 2 hours after ICU arrival
Abnormal RV pressure waveform will be defined as a difference between the RV end-diastolic minus the early-diastolic pressure \> 4 mmHg.
次要结局
- Right ventricular ejection fraction(From arrival to the operating room until 2 hours after ICU arrival)
- Incidence of acute kidney injury (AKI)(Up to 28 days or until hospital discharge)
- Incidence of surgical reintervention for any reasons(Up to 28 days or until hospital discharge)
- Incidence of stroke(Up to 28 days or until hospital discharge)
- Duration of vasopressor requirements (in hours)(Up to 28 days or until hospital discharge)
- Duration of mechanical ventilation (in hours)(Up to 28 days or until hospital discharge)
- Right ventricular fractional area change(From arrival to the operating room until 2 hours after ICU arrival)
- Right ventricular strain(From arrival to the operating room until 2 hours after ICU arrival)
- Incidence of deep sternal wound infection or mediastinitis(Up to 28 days or until hospital discharge)
- Incidence of delirium(Up to 28 days or until hospital discharge)
- Total duration of ICU stay in hours(Up to 28 days or until hospital discharge)
- Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery(From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours.)
- Tricuspid annular plane systolic excursion(From arrival to the operating room until 2 hours after ICU arrival)
- Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery(Up to 28 days or until hospital discharge)
- Incidence of deaths during hospitalisation(Up to 30 days or until hospital discharge)
- Incidence of major bleeding(Up to 28 days or until hospital discharge)
- Duration of hospital stay (in days)(Up to 28 days or until hospital discharge)
- Right ventricular performance index(From arrival to the operating room until 2 hours after ICU arrival)
- Portal flow pulsatility fraction(From arrival to the operating room until 2 hours after ICU arrival)
- Incidence of major morbidity or mortality(Up to 28 days or until hospital discharge)
- Right ventricular stroke work index(From arrival to the operating room until 2 hours after ICU arrival)
- Relative pulmonary pressure(From arrival to the operating room until 2 hours after ICU arrival)
- Pulsatility of femoral venous flow(From arrival to the operating room until 2 hours after ICU arrival)
- Right ventricular function index(From arrival to the operating room until 2 hours after ICU arrival)
- Pulmonary artery pulsatility index (PAPi)(From arrival to the operating room until 2 hours after ICU arrival)
- Compliance of the pulmonary artery (CPA)(From arrival to the operating room until 2 hours after ICU arrival)
研究者
Andre Denault
Principal Investigator
Montreal Heart Institute