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Pulmonary Artery Catheter in Cardiogenic Shock Trial

ConditionsCardiogenic ShockHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorTufts Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

SBP <90 mmHg for more than 30 minutes from baseline SBP

Requires the use of at least 1 vasopressor or inotrope

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary Artery Catheter

    Device

    The pulmonary artery catheter (PAC) is a diagnostic instrument that enables continuous hemodynamic monitoring of cardiac filling pressures, cardiac output, and pulmonary pressures.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Early Pulmonary Artery CatheterExperimental treatment 1 intervention
Group B: No or delayed Pulmonary Artery CatheterNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of participants who die in the hospital

Time frame
Length of stay in hospital, an average of 30 days

Secondary outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts Medical Center

Lead sponsor

Source ClinicalTrials.gov
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