The Pulmonary Artery Catheter in Cardiogenic Shock Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiogenic Shock
- Sponsor
- Tufts Medical Center
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Number of participants who die in the hospital
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
The primary objective of the PACCS trial is to assess if early invasive hemodynamic assessment and ongoing management with a PAC in patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS) is associated with lower in-hospital mortality risk compared to the current standard of care with no or delayed PAC assessment.
Detailed Description
The PACCS trial is a multicenter, randomized, parallel group, adaptive trial that will test the hypothesis that early invasive hemodynamic assessment (within 6 hours of randomization) and ongoing management with a PAC decreases in-hospital mortality compared to clinical management with delayed (beyond 48 hours after randomization) or no PAC-guided assessment among patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS). The trial uses an adaptive sample size re-estimation design. An interim analysis will be performed when the primary endpoint is available for 200 participants and may lead to an increase in the target sample size (minimum sample size 400, maximum sample size 800).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years and ≤90 years
- •Clinical heart failure presentation and left ventricular function as follows: Either 2A or 2B must be present A. Subject has de novo acute decompensated heart failure and shock with an LVEF ≤40% OR B. Subject has acute on chronic heart failure with a documented history of a LVEF ≤40% within 6 months of admission and a current LVEF ≤40% within 24 hours of screening during the current hospitalization.
- •NOTE: The LVEF must be quantitatively measured as ≤ 40% by an echocardiogram within 24 hours of screening. If multiple echocardiograms have been performed within 24 hours, the most recent test must be used to qualify the patient.
- •Cardiogenic Shock (CS) defined by a lactate level ≥ 2.1 mmol/L and any 2 of the following parameters within 24 hours of screening:
- •SBP \<90 mmHg for more than 30 minutes from baseline SBP
- •Requires the use of at least 1 vasopressor or inotrope
- •Requires intra-aortic balloon pump (IABP) support
- •Presence of congestion on exam: JVP elevated, pulmonary edema on CXR or exam, dyspnea at rest, orthopnea, bendopnea, or worsening peripheral or abdominal swelling
- •Initial diagnosis of CS within 24 hours of screening at the enrolling site
- •Patient or legally authorized representative provides informed consent
Exclusion Criteria
- •Primary etiology of shock other than systolic left heart failure including but not limited to: acute myocardial infarction, sepsis, hypovolemia, hemorrhage, severe anemia, primary RV failure, pulmonary embolism, or tamponade.
- •Patient has a durable ventricular assist device or temporary mechanical circulatory support (other than IABP) or PAC prior to enrollment
- •Actively listed for cardiac transplantation (Status 7 patients are eligible for the trial)
- •Patient transferred from another facility with a diagnosis of cardiogenic shock
- •Any known co-morbidity other than heart failure with anticipated survival \< 6 months
- •Pre-enrollment labs (any of the following): International Normalized Ratio (INR) \> 3, Platelet count \< 50k, Hemoglobin \< 7
- •Refractory or recurrent cardiac arrest (\>1 episode requiring defibrillation or cardiopulmonary resuscitation) within 24 hours prior to screening
- •DNR/ DNI status
- •Pregnancy, child-birth within 6 months, or lactation
- •Active infection documented by persistent fever (Temp \> 38.4oC within 24 hours of screening) or confirmed bacteremia
Outcomes
Primary Outcomes
Number of participants who die in the hospital
Time Frame: Length of stay in hospital, an average of 30 days
Secondary Outcomes
- Number of Participants that require Renal Replacement Therapy(Within 96 hours of randomization)
- Number of Participants with in-hospital Cardiac Arrest(Length of stay in hospital, an average of 30 days)
- Length of stay in CCU or ICU(Length of stay in hospital, an average of 30 days)
- Heart failure hospitalizations/emergency room visits(30 days and 6 months after discharge)
- Number of Participants that require Mechanical Ventilation(Length of stay in hospital, an average of 30 days)
- Occurrence of heart transplantation and durable LVAD implantation(Length of stay in hospital, an average of 30 days)
- Death(30 days and 6 months after discharge)
- Admission to an outpatient IV diuretic center(30 days and 6 months after discharge.)