Noninvasive Versus Invasive Assessment of Hemodynamics in the Cardiac Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP.
研究概览
简要总结
This is an investigator-initiated, single-center, single-arm prospective study to compare non-invasive hemodynamic assessment using transthoracic echocardiography (TTE) and lung ultrasound (LUS) and hemodynamic assessment using PAC. Patients who have been hemodynamically assessed using PAC will be invited to participate. Each patient will undergo TTE and LUS immediately after first invasive assessment, and again daily after PAC assessments.
详细描述
Background
Heart Failure
Approximately 600,000 Canadians are living with heart failure (HF) with 50,000 new patients diagnosed each year. Once diagnosed, the median survival for HF patients is 1.7 years for men and 3.2 years for women. As HF progresses, patients experience a worsening in symptom severity, functional capacity, and quality of life. In addition, acute exacerbations of HF is the most frequent cause of unscheduled hospital admissions. Almost 83% of all HF patients will be hospitalized at least once and 43% hospitalized more than three times. However, the mechanisms of HF decompensation are still unclear.
Most drugs (ACE-I/ARB/beta-blockers/MRA) used for the treatment of HF are prescribed because of their ability to improve symptoms or survival. The target doses of these drugs are generally selected on the basis of reported results from randomized controlled trials rather than changes produced in cardiac monitoring of hemodynamics. Interestingly, hemodynamic monitoring has been reportedly indicated in patients where it is difficult to determine their volume status, in addition to those patients refractory to therapy. The ACC/AHA 2013 guidelines3 define the importance of invasive hemodynamic monitoring in patients with:
- severe clinical decompensation in which therapy is limited by elevated filling pressures, hypoperfusion, and vascular tone
- persistent severe symptoms despite a trial of recommended therapies
- the needed or dependency for (or escalation of) pressor and inotropic therapy
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
- •Patients with admitted to the CICU in whom PAC is inserted as standard of care,
排除标准
- •Enrollment into another trial with an active treatment arm
结局指标
主要结局
Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP.
时间窗: Day 1
To determine whether non-invasive assessment of hemodynamics by echocardiogram are comparable to invasive measurements.
次要结局
- Correlation between cardiac output measured by echocardiography (using LVOT diameter and VTI) and by PAC (using thermodilution)(Day 1, Day 2)
- Correlation between right atrial pressure assessed by echocardiography (using IVC diameter and respiratory variation) and by PAC(Day 1, Day 2)
- Correlation between pulmonary pressure assessed by echocardiography (using TR max velocity and estimated RAP) and by PAC(Day 1, Day 2)
- Correlation between pulmonary pressure assessed by echocardiography (using PAT) and by PAC(Day 1, Day 2)
- Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP.(Day 2)
- Correlation between PVR assessed by echocardiography (using PAT) and by PAC(Day 1, Day 2)
- Correlation between right ventricular function assessed by echocardiography (using TAPSE and S') and by PAC (using PAPI and RVSWI)(Day 1, Day 2)