Pulmonary Artery Catheter in Cardiogenic Shock Trial

Launched by TUFTS MEDICAL CENTER · Aug 1, 2022

Keywords

ClinConnect Summary

The Pulmonary Artery Catheter in Cardiogenic Shock Trial (PACCS) is studying whether using a special medical device called a pulmonary artery catheter (PAC) early on can help patients with cardiogenic shock, a serious condition caused by heart failure. The goal is to see if this approach can reduce the risk of death during hospitalization compared to the usual care, which might start with a delay in using the PAC. This trial is currently looking for participants aged 18 to 90 who are experiencing severe heart failure and meet specific medical criteria, such as having a weakened heart function.

If you or a loved one qualifies and chooses to participate, you can expect to receive close monitoring and management of your heart condition with the PAC. This device helps doctors understand how well the heart is pumping blood and can guide treatment decisions. It's important to know that participants will be chosen based on specific health conditions, which means not everyone with heart issues will qualify. This trial aims to improve care for those experiencing acute heart failure and could potentially lead to better outcomes in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years and ≤90 years
• • 2. 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.
• 3. Cardiogenic Shock (CS) defined by a lactate level ≥ 2.1 mmol/L and any 2 of the following parameters within 24 hours of screening:
• • 1. SBP \<90 mmHg for more than 30 minutes from baseline SBP
• • 2. Requires the use of at least 1 vasopressor or inotrope
• • 3. Requires intra-aortic balloon pump (IABP) support
• • 4. Presence of congestion on exam: JVP elevated, pulmonary edema on CXR or exam, dyspnea at rest, orthopnea, bendopnea, or worsening peripheral or abdominal swelling
• • 4. Initial diagnosis of CS within 24 hours of screening at the enrolling site
• • 5. 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
• Exclusion Criteria:
• • 1. 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.
• • 2. Patient has a durable ventricular assist device or temporary mechanical circulatory support (other than IABP) or PAC prior to enrollment
• • 3. Actively listed for cardiac transplantation (Status 7 patients are eligible for the trial)
• • 4. Patient transferred from another facility with a diagnosis of cardiogenic shock
• • 5. Any known co-morbidity other than heart failure with anticipated survival \< 6 months
• • 6. Pre-enrollment labs (any of the following): International Normalized Ratio (INR) \> 3, Platelet count \< 50k, Hemoglobin \< 7
• • 7. Refractory or recurrent cardiac arrest (\>1 episode requiring defibrillation or cardiopulmonary resuscitation) within 24 hours prior to screening
• • 8. DNR/ DNI status
• • 9. Pregnancy, child-birth within 6 months, or lactation
• • 10. Active infection documented by persistent fever (Temp \> 38.4oC within 24 hours of screening) or confirmed bacteremia
• • 11. Implantation of PPM or ICD within past 3 months
• • 12. Mechanical complication of AMI (ie VSD, papillary muscle rupture, flail mitral regurgitation, free wall rupture)
• • 13. Anoxic brain injury
• • 14. On renal replacement therapy prior to enrollment
• • 15. Cardiac surgery within 3 months of current admission
• • 16. Severe aortic, pulmonic, tricuspid stenosis or acute structural mitral regurgitation or infective endocarditis
• • 17. History of cardiac amyloid
• • 18. Congenital heart disease excluding the presence of a bicuspid aortic valve
• • 19. Planned cardiac surgery during admission
• • 20. World Health Organization (WHO) Group I, III, IV, or V pulmonary hypertension
• • 21. Any known contraindication to PAC placement
• • 22. 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
• • 23. 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
• • 24. 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
• • 25. Subject has previously hospitalized for COVID-19 unless he/she has been discharged and asymptomatic for ≥4 weeks
• • 26. Subject is COVID-19 PCR/antigen positive within the prior 4 weeks
• • 27. Subject belongs to a vulnerable population \[defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, members of the armed forces and persons kept in detention\]