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Pulmonary Artery Catheter in Cardiogenic Shock Trial (PACCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05485376
Recruitment Status : Enrolling by invitation
First Posted : August 3, 2022
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Heart Failure Device: Pulmonary Artery Catheter Not Applicable

Detailed Description:
The PACCS trial is a multicenter, randomized, parallel group, adaptive trial that will test the hypothesis that early invasive hemodynamic assessment (within 6 hours of randomization) and ongoing management with a PAC decreases in-hospital mortality compared to clinical management with delayed (beyond 48 hours after randomization) or no PAC-guided assessment among patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS). The trial uses an adaptive sample size re-estimation design. An interim analysis will be performed when the primary endpoint is available for 200 participants and may lead to an increase in the target sample size (minimum sample size 400, maximum sample size 800).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pulmonary Artery Catheter in Cardiogenic Shock Trial
Actual Study Start Date : August 23, 2022
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Early Pulmonary Artery Catheter
If you are in the experimental group a PAC will be placed within 6 hours of randomization and within 24 hours of presentation with ADHF-CS.
Device: Pulmonary Artery Catheter
The pulmonary artery catheter (PAC) is a diagnostic instrument that enables continuous hemodynamic monitoring of cardiac filling pressures, cardiac output, and pulmonary pressures.

No Intervention: No or delayed Pulmonary Artery Catheter
If you are in the control group, a PAC will not be placed during hospitalization or may be placed 48 hours after randomization into the study. Placement of a PAC within 48 hours is only permitted for emergencies.



Primary Outcome Measures :
  1. Number of participants who die in the hospital [ Time Frame: Length of stay in hospital, an average of 30 days ]

Secondary Outcome Measures :
  1. Number of Participants with in-hospital Cardiac Arrest [ Time Frame: Length of stay in hospital, an average of 30 days ]
  2. Number of Participants that require Mechanical Ventilation [ Time Frame: Length of stay in hospital, an average of 30 days ]
  3. Number of Participants that require Renal Replacement Therapy [ Time Frame: Within 96 hours of randomization ]
  4. Length of stay in CCU or ICU [ Time Frame: Length of stay in hospital, an average of 30 days ]
  5. Occurrence of heart transplantation and durable LVAD implantation [ Time Frame: Length of stay in hospital, an average of 30 days ]
  6. Death [ Time Frame: 30 days and 6 months after discharge ]
  7. Heart failure hospitalizations/emergency room visits [ Time Frame: 30 days and 6 months after discharge ]
  8. Admission to an outpatient IV diuretic center [ Time Frame: 30 days and 6 months after discharge. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05485376


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Navin K Kapur, MD nkapur@tuftsmedicalcenter.org
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT05485376    
Other Study ID Numbers: 00002564
First Posted: August 3, 2022    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tufts Medical Center:
Pulmonary Artery Catheter
Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Infarction
Ischemia
Necrosis