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Pulmonary Artery Catheter in Cardiogenic Shock Trial (PACCS)

Primary Purpose

Cardiogenic Shock, Heart Failure

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmonary Artery Catheter
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring Pulmonary Artery Catheter

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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]

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early Pulmonary Artery Catheter

No or delayed Pulmonary Artery Catheter

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants who die in the hospital

Secondary Outcome Measures

Number of Participants with in-hospital Cardiac Arrest
Number of Participants that require Mechanical Ventilation
Number of Participants that require Renal Replacement Therapy
Length of stay in CCU or ICU
Occurrence of heart transplantation and durable LVAD implantation
Death
Heart failure hospitalizations/emergency room visits
Admission to an outpatient IV diuretic center

Full Information

First Posted
June 17, 2022
Last Updated
September 25, 2022
Sponsor
Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05485376
Brief Title
Pulmonary Artery Catheter in Cardiogenic Shock Trial
Acronym
PACCS
Official Title
The Pulmonary Artery Catheter in Cardiogenic Shock Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock, Heart Failure
Keywords
Pulmonary Artery Catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Pulmonary Artery Catheter
Arm Type
Experimental
Arm Description
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.
Arm Title
No or delayed Pulmonary Artery Catheter
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pulmonary Artery Catheter
Intervention Description
The pulmonary artery catheter (PAC) is a diagnostic instrument that enables continuous hemodynamic monitoring of cardiac filling pressures, cardiac output, and pulmonary pressures.
Primary Outcome Measure Information:
Title
Number of participants who die in the hospital
Time Frame
Length of stay in hospital, an average of 30 days
Secondary Outcome Measure Information:
Title
Number of Participants with in-hospital Cardiac Arrest
Time Frame
Length of stay in hospital, an average of 30 days
Title
Number of Participants that require Mechanical Ventilation
Time Frame
Length of stay in hospital, an average of 30 days
Title
Number of Participants that require Renal Replacement Therapy
Time Frame
Within 96 hours of randomization
Title
Length of stay in CCU or ICU
Time Frame
Length of stay in hospital, an average of 30 days
Title
Occurrence of heart transplantation and durable LVAD implantation
Time Frame
Length of stay in hospital, an average of 30 days
Title
Death
Time Frame
30 days and 6 months after discharge
Title
Heart failure hospitalizations/emergency room visits
Time Frame
30 days and 6 months after discharge
Title
Admission to an outpatient IV diuretic center
Time Frame
30 days and 6 months after discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Subject is COVID-19 PCR/antigen positive within the prior 4 weeks 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]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Navin K Kapur, MD
Organizational Affiliation
nkapur@tuftsmedicalcenter.org
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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Pulmonary Artery Catheter in Cardiogenic Shock Trial

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