NCT05485376
Pulmonary Artery Catheter in Cardiogenic Shock Trial
Recruiting · Not Applicable · Tufts Medical Center · registry updated 2025-10-29
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
Exclusion
- 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