Arterial Compliance as a Predictor of Clinical Outcomes With Intra-aortic Balloon Counterpulsation: A Prospective Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cardiac Output (L/min)
研究概览
简要总结
The investigators intend to study how baseline arterial compliance (as defined by stroke volume/pulse pressure) influences the clinical success of intraaortic balloon counterpulsation (IABC) in patients with cardiogenic shock (CS). The investigators aim to compare clinical outcomes in CS patients requiring IABC with normal compliance versus low compliance. The study will enroll patients undergoing IABC that are clinically indicated. Baseline hemodynamic measurements will be obtained and then patients would be stratified based on their compliance. Post IABC, serial hemodynamic measurements will be obtained and compared between groups. Patients will continue to be followed longitudinally until the IABC has been discontinued for any reason. The proposed study will yield results that will aid in developing a larger clinical trial and ultimately assist clinicians in determining if IABC is appropriate therapy for patients in cardiogenic shock.
详细描述
This study will focus on patients in cardiogenic shock (CS) that will be undergoing clinically indicated intraaortic balloon counterpulsation (IABC) insertion and right heart catheterization. Prior to IABC insertion a patient will have their clinically indicated right heart catheterization. The investigators will record these baseline hemodynamic parameters, including (but not limited to) stroke volume and arterial pulse pressure.
After IABC insertion is completed, repeat hemodynamic measurements will be obtained approximately 30 minutes later. Repeat hemodynamic measurements will be recorded at approximately 3-6 hours following the procedure, and 24 hours following the procedure. The act of recording hemodynamic measurements is part of the usual clinical management of patients with IABC.
The patients will continue be followed longitudinally until their IABC course has completed, either due to resolution of CS, exchange for a separate device, heart transplantation, durable Left Ventricular Assist Device (LVAD) implant, or patient death.
The investigators hypothesize that patients with low arterial compliance will have greater improvements in cardiac output and cardiac filling pressures compared to patients with normal compliance. The specific aims are to (1) compare hemodynamic changes with IABC in cardiogenic shock patients with low compliance vs those with normal compliance and (2) to determine a cutoff value of compliance that can be used for future larger clinical trials.
The proposed study will yield results that will aid in developing a larger clinical trial and ultimately assist clinicians in determining if IABC is appropriate therapy for patients in cardiogenic shock.
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
- •Age ≥18 years old
- •Cardiogenic shock
- •Undergoing Intra-aortic Balloon Counterpulsation (IABC) as part of clinical care
- •Able to provide consent or have power of attorney or next of kin provide consent
排除标准
- •Age <18 years old
- •Unable to consent or does not have power of attorney or next of kin to consent
结局指标
主要结局
Cardiac Output (L/min)
时间窗: 24 hours
次要结局
- Right Atrium Pressure (mmHg)(24 hours)
- Systolic Blood Pressure (mmHg)(30 minutes)
- Pulmonary Artery Oxygen Saturation (%)(24 hours)
- Ultimate Disposition(Longitudinal Follow-Up (approximately 3 months))
- Total Bilirubin (mg/dL)(24 hours)
- ALT (U/L)(24 hours)
- AST (U/L)(24 hours)
- Creatine Clearance/GFR(24 hours)
- Creatine (mg/dL)(24 hours)
- Lactate millimoles per liter (mmol/L)(24 hours)
- Pulmonary Artery Compliance (mmHg)(24 hours)
- Right Ventricular Stroke Work Index (g·m-²·beat-¹)(24 hours)
- Pulmonary Artery Pulsatility Index (PAPi)(24 hours)
- Pulmonary Vascular Resistance (dynes/cm⁵)(24 hours)
- Systemic Vascular Resistance (mmHg/L/min)(24 hours)
- Pulmonary Capillary Wedge Pressure (mmHg)(24 hours)
- Diastolic Pulmonary Arterial Pressure (mmHg)(24 hours)
- Systolic Pulmonary Artery Pressure (mmHg)(24 hours)
- Aortic Pulsatility Index (API)(24 hours)
- Cardiac Power Input (W/m²)(24 hours)
- Cardiac Power Output (Watts)(24 hours)
- Stroke Volume (mL)(24 hours)
- Cardiac Index (L/min/m²)(24 hours)
- Heart Rhythm(24 hours)
- Heart Rate (beats per minute)(24 hours)
- Mean Arterial Pressure (mmHg)(24 hours)
- Diastolic Blood Pressure (mmHg)(24 hours)
- Systolic Blood Pressure (mmHg)(24 hours)
- Pulmonary Artery Compliance (mmHg)(3-6 hours)
- Right Ventricular Stroke Work Index (g·m-²·beat-¹)(3-6 hours)
- Pulmonary Artery Pulsatility Index (PAPi)(3-6 hours)
- Pulmonary Vascular Resistance (dynes/cm⁵)(3-6 hours)
- Systemic Vascular Resistance (mmHg/L/min)(3-6 hours)
- Pulmonary Capillary Wedge Pressure (mmHg)(3-6 hours)
- Diastolic Pulmonary Arterial Pressure (mmHg)(3-6 hours)
- Systolic Pulmonary Artery Pressure (mmHg)(3-6 hours)
- Right Atrium Pressure (mmHg)(3-6 hours)
- Aortic Pulsatility Index (API)(3-6 hours)
- Cardiac Power Input (W/m²)(3-6 hours)
- Cardiac Power Output (Watts)(3-6 hours)
- Stroke Volume (mL)(3-6 hours)
- Cardiac Index (L/min/m²)(3-6 hours)
- Cardiac Output (L/min)(3-6 hours)
- Pulmonary Artery Oxygen Saturation (%)(3-6 hours)
- Heart Rhythm(3-6 hours)
- Heart Rate (beats per minute)(3-6 hours)
- Mean Arterial Pressure (mmHg)(3-6 hours)
- Diastolic Blood Pressure (mmHg)(3-6 hours)
- Systolic Blood Pressure (mmHg)(3-6 hours)
- Pulmonary Artery Compliance (mmHg)(30 minutes)
- Right Ventricular Stroke Work Index (g·m-²·beat-¹)(30 minutes)
- Pulmonary Artery Pulsatility Index (PAPi)(30 minutes)
- Pulmonary Vascular Resistance (dynes/cm⁵)(30 minutes)
- Systemic Vascular Resistance (mmHg/L/min)(30 minutes)
- Pulmonary Capillary Wedge Pressure (mmHg)(30 minutes)
- Diastolic Pulmonary Arterial Pressure (mmHg)(30 minutes)
- Systolic Pulmonary Artery Pressure (mmHg)(30 minutes)
- Right Atrium Pressure (mmHg)(30 minutes)
- Aortic Pulsatility Index (API)(30 minutes)
- Cardiac Power Input (W/m²)(30 minutes)
- Stroke Volume (mL)(30 minutes)
- Cardiac Power Output (Watts)(30 minutes)
- Cardiac Index (L/min/m²)(30 minutes)
- Cardiac Output (L/min)(30 minutes)
- Pulmonary Artery Oxygen Saturation (%)(30 minutes)
- Heart Rhythm(30 minutes)
- Heart Rate (beats per minute)(30 minutes)
- Mean Arterial Pressure (mmHg)(30 minutes)
- Diastolic Blood Pressure (mmHg)(30 minutes)
研究者
Matthew Delfiner
Principal Investigator: Matthew S Delfiner DO, MS
Thomas Jefferson University