Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
Trial Parameters
Brief Summary
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
Eligibility Criteria
Inclusion Criteria: 1. Subject or legal representative has signed Informed Consent Form (ICF) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator. 2. Age ≥ 18 years 3. NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF). 4. Survive to discharge during a current hospital admission with cardiogenic shock (CS) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure \< 90 mmHg for \> 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output \< 30 mL/h, or serum lactate \> 2 mmol/L (5). Hemodynamic criteria include cardiac index ≤ 1.8 L/min/m2 without vasoactive pharmacologic agents, or cardiac index