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New treatment option for Cardiogenic Shock
Official title Pulmonary Artery Catheter in Cardiogenic Shock Trial
ClinicalTrials.gov ID: NCT05485376
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join 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...
- 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
You likely can't join if
- Primary etiology of shock other than systolic left heart failure including but not limited to: acute myocardial infarction, sepsis, hypovolemia...
- 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
See the full eligibility 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...
- 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 people. No recruitment materials will be given to potential people. No identifiable...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.