Pulmonary Artery Catheter for Cardiogenic Shock

(PACCS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Navin Kapur, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Tufts Medical Center

Disqualifiers: Myocardial infarction, Sepsis, Anemia, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Pulmonary Artery Catheter for Cardiogenic Shock?

The research indicates that the effectiveness of using a pulmonary artery catheter (a device used to measure heart and lung pressures) in patients with cardiogenic shock is still debated, with studies exploring its impact on survival rates but not providing clear conclusions. ^{1 2 3 4 5}

Is the pulmonary artery catheter generally safe for use in humans?

The pulmonary artery catheter, also known as the Swan-Ganz catheter, can lead to complications such as hematoma (bruising), pneumothorax (collapsed lung), and in rare cases, serious vascular damage like pulmonary artery rupture. Careful insertion techniques and monitoring can help reduce these risks. ^{2 3 6 7 8}

How is the pulmonary artery catheter treatment different for cardiogenic shock?

The pulmonary artery catheter (PAC) is unique for treating cardiogenic shock because it allows doctors to directly measure heart and lung pressures, providing detailed information to guide treatment decisions. Unlike other treatments, it involves inserting a catheter (a thin tube) into the pulmonary artery to monitor heart function in real-time, which can be crucial for managing this severe condition. ^{2 3 4 6 9}

Eligibility Criteria

This trial is for adults aged 18-90 with heart failure leading to cardiogenic shock, diagnosed within the last 24 hours. Participants must consent and meet specific criteria related to heart function and lactate levels. Exclusions include severe other conditions, recent COVID-19 hospitalization, certain prior treatments like ventricular assist devices or transplants, active infections, bleeding risks, and pregnancy.

Inclusion Criteria

You have a condition called cardiogenic shock, which is identified by specific test results showing high lactate levels and other specific measurements.

No identifiable data will be retained for subjects that are determined to be ineligible

A HIPAA waiver for screening is requested to identify potential subjects

Exclusion Criteria

I am on the waiting list for a heart transplant.

You have a "do not resuscitate" or "do not intubate" status.

Your blood tests show a high INR level, a low platelet count, or low hemoglobin levels.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Early invasive hemodynamic assessment with a PAC within 6 hours of randomization for the experimental group, or no/delayed PAC for the control group

Duration of hospitalization

Follow-up

Participants are monitored for in-hospital mortality and other outcomes

Until discharge

Treatment Details

Interventions

• Pulmonary Artery Catheter (Hemodynamic Monitoring Device)

Trial Overview The PACCS trial is testing if using a Pulmonary Artery Catheter (PAC) right away in patients with acute heart failure-induced cardiogenic shock can reduce the risk of dying in the hospital compared to standard care without immediate PAC use.

Participant Groups

Group I: Early Pulmonary Artery Catheter Experimental Treatment 1 Intervention

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.

Group II: No or delayed Pulmonary Artery Catheter Active Control 1 Intervention

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.

Pulmonary Artery Catheter is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Pulmonary Artery Catheter for:

• Cardiogenic shock
• Pulmonary hypertension
• Severe heart failure
• Complex heart attacks
• Unstable conditions before or after surgery
• Severe preeclampsia

🇪🇺 Approved in European Union as Pulmonary Artery Catheter for:

• Cardiogenic shock
• Pulmonary hypertension
• Severe heart failure
• Complex heart attacks
• Unstable conditions before or after surgery
• Severe preeclampsia

🇨🇦 Approved in Canada as Pulmonary Artery Catheter for:

• Cardiogenic shock
• Pulmonary hypertension
• Severe heart failure
• Complex heart attacks
• Unstable conditions before or after surgery
• Severe preeclampsia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Tufts Medical Center Boston, MA

Who Is Running the Clinical Trial?

Tufts Medical Center Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies. [2022] To investigate the impact of pulmonary artery catheter (PAC) monitoring on survival of cardiogenic shock(CS), in the light of the controversies in available evidence.

2. United States pubmed.ncbi.nlm.nih.gov

Pulmonary artery catheterization in patients with cardiogenic shock: a systematic review and meta-analysis. [2022] Cardiogenic shock carries high morbidity and mortality. The purpose of this review was to determine the safety and efficacy of pulmonary artery catheterization (PAC) in adult patients hospitalized with cardiogenic shock.

3. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Pulmonary Artery Catheter Use on Short- and Long-Term Mortality in Patients with Cardiogenic Shock. [2018] The impact of pulmonary artery catheterization (PAC) on survival in patients with cardiogenic shock (CS) is not well established. This study aimed to assess whether Swan-Ganz catheter monitoring is related to short- and long-term mortality in patients with CS.

4. United States pubmed.ncbi.nlm.nih.gov

Clinical impact of pulmonary artery catheter in patients with cardiogenic shock: A systematic review and meta-analysis. [2023] The clinical utility of the pulmonary artery catheter (PAC) for the management of cardiogenic shock (CS) remains controversial. We performed a systematic review and meta-analysis exploring the association between PAC use and mortality among patients with CS.

5. England pubmed.ncbi.nlm.nih.gov

Pulmonary Artery Catheter Usage and Impact on Mortality in Patients with Cardiogenic Shock: Results from a Canadian, Single Centre Registry. [2023] Hemodynamic assessment for cardiogenic shock (CS) phenotyping in patients has led to renewed interest in the use of pulmonary artery catheters (PAC).

6. Japan pubmed.ncbi.nlm.nih.gov

[Insertion procedure of the Swan-Ganz catheter]. [2010] The Swan-Ganz catheter (the pulmonary artery catheter: PAC) has been used to examine the heart diseases and to evaluate the hemodynamics by the physician in the catheter laboratory and beside the patient's bed. It is also used to monitor the hemodynamics during the cardiac surgery in the operating theater and to manage the patient in the intensive care unit (ICU) postoperatively. A very careful insertion technique is mandatory to avoid various serious complications, such as hematoma formation, arterial centesis, pneumothorax, hemothorax, perforation from cardiac chambers, rupture of the pulmonary artery, and so on. To reduce these complications, standardization of the insertion technique could be useful. When a complication unfortunately occurrs during insertion before surgery, it should be considered to abandon the following operation to avoid catastrophe.

7. Poland pubmed.ncbi.nlm.nih.gov

Pulmonary artery rupture as a complication of Swan-Ganz catheter application. Diagnosis and endovascular treatment: a single centre's experience. [2022] The placement of a Swan-Ganz catheter into the pulmonary artery may lead to a number of complications (2-17%). In less than 0.2% of cases Swan-Ganz catheterization results in serious vascular damage - pulmonary artery rupture (PAR). This paper presents two distinct forms of iatrogenic PAR treated endovascularly using different vascular devices.

8. United States pubmed.ncbi.nlm.nih.gov

The two-headed swan. [2018] Pulmonary artery catheterization is a frequent procedure for hemodynamic monitoring in critically ill patients or high-risk surgical patients. Mechanical and infectious complications are recognized, though catheter dysfunction and malposition are more frequent and often require clinical intervention. We present the case of a Swan-Ganz catheter with the appearance of a mechanical fracture at the distal end, which required clinical and radiographic investigation to determine the nature of the aberrancy. The evaluation of a malfunctioning pulmonary artery catheter (PAC) is a frequent occurrence in the intensive care unit and requires careful clinical consideration and radiographic examination.

9. England pubmed.ncbi.nlm.nih.gov

Pulmonary artery catheter use in acute myocardial infarction-cardiogenic shock. [2021] The aim of this study is to evaluate the contemporary use of a pulmonary artery catheter (PAC) in acute myocardial infarction-cardiogenic shock (AMI-CS).