The Clinical Significance of Portal Hypertension After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Duration of invasive life support after cardiac surgery. (Tpod)
研究概览
简要总结
Portal flow pulsatility detected by Doppler ultrasound is an echographic marker of cardiogenic portal hypertension from right ventricular failure and is associated with adverse outcomes based on previous studies performed at the Montreal Heart Institute. This multicenter prospective cohort study aims to determine if portal flow pulsatility after cardiopulmonary bypass separation is associated with a longer requirement of life support after cardiac surgery.
详细描述
Hypothesis
Portal flow pulsatility detected by Doppler ultrasound during cardiac surgery is an echographic marker of cardiogenic portal hypertension from right ventricular failure and is associated with adverse clinical outcomes.
Background: Peri-operative right ventricular failure is associated with a high mortality rate. In this context, organ perfusion is hampered by both the reduction of cardiac output and venous congestion from the elevation of central venous pressure. The clinician's objective is to appreciate the hemodynamic impact on end-organs in an effort to adjust the therapy accordingly since the ultimate goal is to optimize their perfusion. Based on this rationale, organ specific blood flow assessment using Doppler ultrasound could be used to personalize management. In order to non-invasively assess the presence of cardiogenic portal hypertension, Doppler ultrasound can be used to detect portal flow pulsatility, an abnormal variation in the velocity of blood flow within the main portal vein. In two single-center cohort studies, the presence of portal flow pulsatility after cardiac surgery was independently associated with post-operative complications such as major bleeding, acute kidney injury (AKI) and delirium as well as increased length of intensive care unit (ICU) stay.
Specific Objectives: This multi-center cohort study aim to determine whether the association between portal flow pulsatility and organ dysfunction seen in previous studies is present across multiple cardiac surgery centers.
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
- •Adult patients (≥18 years old) and able to give informed consent undergoing cardiac surgery with the use of CPB for whom peri-operative TEE is planned.
- •High surgical risk defined as at least one of the following:
- •Multiple surgical procedures planned
- •EuroSCORE II ≥ 5%
- •Known pulmonary hypertension (mPAP>25mmHg or sPAP>40mmHg).
排除标准
- •Patient with a critical pre-operative state defined as vasopressor requirement, mechanical circulatory support, dialysis, mechanical ventilation or cardiac arrest necessitating resuscitation.
- •Patient with known condition that could interfere with portal flow assessment or interpretation (liver cirrhosis, portal vein thrombosis)
- •Planned cardiac transplantation
- •Planned ventricular assist device implantation
结局指标
主要结局
Duration of invasive life support after cardiac surgery. (Tpod)
时间窗: Up to 28 days
Defined as the time of Persistent Organ Dysfunction (POD) or Death
次要结局
- Deep sternal wound infection or mediastinitis(Up to 28 days)
- Delirium(Up to 28 days)
- Total duration of ICU stay in hours(Up to 28 days)
- Duration of hospital stay (in days)(Up to 28 days)
- All cause death(Up to 28 days)
- Surgical reintervention for any reasons(Up to 28 days)
- Major bleeding defined by the Bleeding Academic Research Consortium (BARC)(Up to 28 days)
- Stroke(Up to 28 days)
- Duration of mechanical ventilation (in hours)(Up to 28 days)
- Acute kidney injury according to KDIGO serum creatinine criteria(Up to 28 days)
- A composite outcome of major morbidity or mortality (41): including death, prolonged ventilation, stroke, renal failure (Stage ≥2), deep sternal wound infection and reoperation for any reason.(Up to 28 days)
研究者
Andre Denault
Principal investigator
Montreal Heart Institute