Pulmonary Artery Catheter in Cardiogenic Shock Trial

Recruiting now · Not applicable

Conditions studied: Cardiogenic Shock, Heart Failure

In brief

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.

Key facts

Study ID: NCT05485376
Run by: Tufts Medical Center
People needed: 400
Starts: 2022-08-23
Expected to finish: 2026-09-01
Last updated by the study team: 2025-10-29

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
A HIPAA waiver for screening is requested to identify potential subjects. No recruitment materials will be given to potential subjects. No identifiable data will be retained for subjects that are determined to be ineligible

You may not qualify if…

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
Implantation of PPM or ICD within past 3 months
Mechanical complication of AMI (ie VSD, papillary muscle rupture, flail mitral regurgitation, free wall rupture)
Anoxic brain injury
On renal replacement therapy prior to enrollment
Cardiac surgery within 3 months of current admission
Severe aortic, pulmonic, tricuspid stenosis or acute structural mitral regurgitation or infective endocarditis
History of cardiac amyloid
Congenital heart disease excluding the presence of a bicuspid aortic valve
Planned cardiac surgery during admission
World Health Organization (WHO) Group I, III, IV, or V pulmonary hypertension
Any known contraindication to PAC placement
Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
Any medical or psychiatric condition such as dementia, alcoholism, or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up
Prior stroke with any permanent neurologic deficit or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass
Subject has previously hospitalized for COVID-19 unless he/she has been discharged and asymptomatic for ≥4 weeks

Where it is running

Tufts Medical Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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