Actively Recruiting
Pulmonary Artery Catheter in Cardiogenic Shock Trial
Led by Tufts Medical Center · Updated on 2025-10-29
400
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pulmonary Artery Catheter in Cardiogenic Shock Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 90 years
- Clinical heart failure with left ventricular ejection fraction (LVEF) of 40% or less
- Either new acute decompensated heart failure with shock or acute on chronic heart failure with documented LVEF 40% within 6 months and current LVEF 40% within 24 hours
- Cardiogenic shock defined by lactate 2.1 mmol/L and at least two of: low systolic blood pressure for over 30 minutes, use of vasopressors or inotropes, intra-aortic balloon pump support, or signs of congestion
- Initial diagnosis of cardiogenic shock within 24 hours of screening
- Informed consent provided by patient or legal representative
You will not qualify if you...
- Shock caused by conditions other than systolic left heart failure, such as myocardial infarction, sepsis, hypovolemia, hemorrhage, anemia, right heart failure, pulmonary embolism, or tamponade
- Existing ventricular assist device or mechanical circulatory support (except intra-aortic balloon pump) or prior pulmonary artery catheter
- Active listing for cardiac transplantation except Status 7
- Transfer from another hospital with cardiogenic shock diagnosis
- Other serious illnesses with expected survival under 6 months
- Abnormal lab values: INR over 3, platelet count under 50,000, hemoglobin under 7
- Recurrent or refractory cardiac arrest within 24 hours before screening
- Do-not-resuscitate or do-not-intubate status
- Pregnancy, childbirth within 6 months, or lactation
- Active infection with fever over 38.46C or bacteremia
- Pacemaker or defibrillator implanted within 3 months
- Mechanical complications from heart attack
- Brain injury due to lack of oxygen
- Prior kidney replacement therapy
- Recent cardiac surgery within 3 months
- Severe valve disease or infective endocarditis
- History of cardiac amyloidosis
- Congenital heart disease except bicuspid aortic valve
- Planned cardiac surgery during admission
- Certain types of pulmonary hypertension
- Known contraindications to pulmonary artery catheter placement
- Participation in other investigational drug/device trials not completed
- Medical or psychiatric conditions interfering with consent or study procedures
- Prior stroke with lasting neurological deficit or brain bleeding conditions
- Recent or current COVID-19 infection
- Belonging to vulnerable populations unable to consent or follow procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
Research Team
K
Karol Walec
CONTACT
V
Vanessa Palomo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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