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.
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.
Study Type
OBSERVATIONAL
Enrollment
20
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGCardiac Output (L/min)
Time frame: 24 hours
Systolic Blood Pressure (mmHg)
Time frame: 30 minutes
Pulmonary Artery Oxygen Saturation (%)
Time frame: 24 hours
Ultimate Disposition
Hospital death
Time frame: Longitudinal Follow-Up (approximately 3 months)
Total Bilirubin (mg/dL)
participant laboratory value
Time frame: 24 hours
ALT (U/L)
participant laboratory value
Time frame: 24 hours
AST (U/L)
participant laboratory value
Time frame: 24 hours
Creatine Clearance/GFR
Time frame: 24 hours
Creatine (mg/dL)
participant laboratory value
Time frame: 24 hours
Lactate millimoles per liter (mmol/L)
participant laboratory value
Time frame: 24 hours
Pulmonary Artery Compliance (mmHg)
Time frame: 24 hours
Right Ventricular Stroke Work Index (g·m-²·beat-¹)
Time frame: 24 hours
Pulmonary Artery Pulsatility Index (PAPi)
calculated measurement
Time frame: 24 hours
Pulmonary Vascular Resistance (dynes/cm⁵)
Time frame: 24 hours
Systemic Vascular Resistance (mmHg/L/min)
Time frame: 24 hours
Pulmonary Capillary Wedge Pressure (mmHg)
Time frame: 24 hours
Diastolic Pulmonary Arterial Pressure (mmHg)
Time frame: 24 hours
Systolic Pulmonary Artery Pressure (mmHg)
Time frame: 24 hours
Right Atrium Pressure (mmHg)
report measurement
Time frame: 24 hours
Aortic Pulsatility Index (API)
calculated measurement
Time frame: 24 hours
Cardiac Power Input (W/m²)
Time frame: 24 hours
Cardiac Power Output (Watts)
Time frame: 24 hours
Stroke Volume (mL)
Time frame: 24 hours
Cardiac Index (L/min/m²)
Time frame: 24 hours
Heart Rhythm
Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other
Time frame: 24 hours
Heart Rate (beats per minute)
Time frame: 24 hours
Mean Arterial Pressure (mmHg)
Time frame: 24 hours
Diastolic Blood Pressure (mmHg)
Time frame: 24 hours
Systolic Blood Pressure (mmHg)
Time frame: 24 hours
Pulmonary Artery Compliance (mmHg)
Time frame: 3-6 hours
Right Ventricular Stroke Work Index (g·m-²·beat-¹)
Time frame: 3-6 hours
Pulmonary Artery Pulsatility Index (PAPi)
calculated measurement
Time frame: 3-6 hours
Pulmonary Vascular Resistance (dynes/cm⁵)
Time frame: 3-6 hours
Systemic Vascular Resistance (mmHg/L/min)
Time frame: 3-6 hours
Pulmonary Capillary Wedge Pressure (mmHg)
Time frame: 3-6 hours
Diastolic Pulmonary Arterial Pressure (mmHg)
Time frame: 3-6 hours
Systolic Pulmonary Artery Pressure (mmHg)
Time frame: 3-6 hours
Right Atrium Pressure (mmHg)
report measurement
Time frame: 3-6 hours
Aortic Pulsatility Index (API)
calculated measurement
Time frame: 3-6 hours
Cardiac Power Input (W/m²)
Time frame: 3-6 hours
Cardiac Power Output (Watts)
Time frame: 3-6 hours
Stroke Volume (mL)
Time frame: 3-6 hours
Cardiac Index (L/min/m²)
Time frame: 3-6 hours
Cardiac Output (L/min)
Time frame: 3-6 hours
Pulmonary Artery Oxygen Saturation (%)
Time frame: 3-6 hours
Heart Rhythm
Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other
Time frame: 3-6 hours
Heart Rate (beats per minute)
Time frame: 3-6 hours
Mean Arterial Pressure (mmHg)
Time frame: 3-6 hours
Diastolic Blood Pressure (mmHg)
Time frame: 3-6 hours
Systolic Blood Pressure (mmHg)
Time frame: 3-6 hours
Pulmonary Artery Compliance (mmHg)
Time frame: 30 minutes
Right Ventricular Stroke Work Index (g·m-²·beat-¹)
Time frame: 30 minutes
Pulmonary Artery Pulsatility Index (PAPi)
calculated measurement
Time frame: 30 minutes
Pulmonary Vascular Resistance (dynes/cm⁵)
Time frame: 30 minutes
Systemic Vascular Resistance (mmHg/L/min)
Time frame: 30 minutes
Pulmonary Capillary Wedge Pressure (mmHg)
Time frame: 30 minutes
Diastolic Pulmonary Arterial Pressure (mmHg)
Time frame: 30 minutes
Systolic Pulmonary Artery Pressure (mmHg)
Time frame: 30 minutes
Right Atrium Pressure (mmHg)
report measurement
Time frame: 30 minutes
Aortic Pulsatility Index (API)
calculated measurement
Time frame: 30 minutes
Cardiac Power Input (W/m²)
Time frame: 30 minutes
Stroke Volume (mL)
Time frame: 30 minutes
Cardiac Power Output (Watts)
Time frame: 30 minutes
Cardiac Index (L/min/m²)
Time frame: 30 minutes
Cardiac Output (L/min)
Time frame: 30 minutes
Pulmonary Artery Oxygen Saturation (%)
Time frame: 30 minutes
Heart Rhythm
Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other
Time frame: 30 minutes
Heart Rate (beats per minute)
Time frame: 30 minutes
Mean Arterial Pressure (mmHg)
Time frame: 30 minutes
Diastolic Blood Pressure (mmHg)
Time frame: 30 minutes
Ultimate Disposition
Heart recovery with discharge (alive)
Time frame: Longitudinal Follow-Up (approximately 3 months)
Ultimate Disposition
Left Ventricular Assist Device (LVAD)
Time frame: Longitudinal Follow-Up (approximately 3 months)
Ultimate Disposition
Transplant
Time frame: Longitudinal Follow-Up (approximately 3 months)
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