Pulmonary Artery Catheter in Cardiogenic Shock Trial
PACCS
The Pulmonary Artery Catheter in Cardiogenic Shock Trial
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 3, 2022
CompletedStudy Start
First participant enrolled
August 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
October 29, 2025
October 1, 2025
4 years
June 17, 2022
October 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants who die in the hospital
Length of stay in hospital, an average of 30 days
Secondary Outcomes (8)
Number of Participants with in-hospital Cardiac Arrest
Length of stay in hospital, an average of 30 days
Number of Participants that require Mechanical Ventilation
Length of stay in hospital, an average of 30 days
Number of Participants that require Renal Replacement Therapy
Within 96 hours of randomization
Length of stay in CCU or ICU
Length of stay in hospital, an average of 30 days
Occurrence of heart transplantation and durable LVAD implantation
Length of stay in hospital, an average of 30 days
- +3 more secondary outcomes
Study Arms (2)
Early Pulmonary Artery Catheter
EXPERIMENTALIf 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.
No or delayed Pulmonary Artery Catheter
NO INTERVENTIONIf 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.
Interventions
The pulmonary artery catheter (PAC) is a diagnostic instrument that enables continuous hemodynamic monitoring of cardiac filling pressures, cardiac output, and pulmonary pressures.
Eligibility Criteria
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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Related Publications (1)
Filipescu R, Collins SP, Radu RI, Ben Gal T, Antohi L, Abdelhamid M, Geavlete O, Pana M, Farmakis D, Matei DC, Savarese G, Margineanu C, Polovina M, Miro O, Guz D, Palazzuoli A, Masip J, Adamo M, Ambrosy AP, Chioncel O. Therapeutic Advances in the Management of Cardiogenic Shock. Am J Ther. 2026 Jan 15. doi: 10.1097/MJT.0000000000002025. Online ahead of print.
PMID: 41543923DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Navin K Kapur, MD
nkapur@tuftsmedicalcenter.org
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2022
First Posted
August 3, 2022
Study Start
August 23, 2022
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
October 29, 2025
Record last verified: 2025-10