Pulmonary Artery Catheter in Cardiogenic Shock Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorTufts Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
SBP <90 mmHg for more than 30 minutes from baseline SBP
Requires the use of at least 1 vasopressor or inotrope
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pulmonary Artery Catheter
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov